Appliance, Fixation, Spinal Intervertebral Body
FDA product code KWQ · Class II (moderate risk) · 21 CFR 888.3060 · Orthopedic
667510(k) clearances
0PMA approvals
203recalls
Implantimplanted device
Manufacturers
- Nuvasive, Inc. 21
- Medtronic Sofamor Danek 20
- K2m, Inc. 20
- Globus Medical, Inc. 15
- Life Spine, Inc. 14
- Synthes Spine 13
- Blackstone Medical, Inc. 13
- Synthes (Usa) 13
- Pioneer Surgical Technology 12
- Acromed Corp. 11
- Aesculap, Inc. 11
- Depuy Spine, Inc. 10
- Howmedica Osteonics Corp. 10
- Ebi, L.P. 10
- Alphatec Spine, Inc. 9
- Medtronic Sofamor Danek USA, Inc. 9
- L&K BIOMED Co., Ltd. 8
- X-Spine Systems, Inc. 7
- U&I Corporation 7
- Sofamor Danek USA,Inc. 7
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261309 | Palisades Buttress Plate SystemKWQ · Traditional | Bethesda Medical Devices, LLC | 07/16/2026SE |
| K252776 | ARIES Anterior Cervical Plate SystemsKWQ · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/14/2026SE |
| K261112 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | L&K BIOMED Co., Ltd. | 05/06/2026SE |
| K260570 | corra cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 04/22/2026SE |
| K260697 | VyPlate Anterior Cervical Plate SystemKWQ · Special | Vy Spine, LLC | 03/27/2026SE |
| K260015 | ANTERIS Thoracolumbar Plate SystemKWQ · Traditional | SpineCraft | 03/04/2026SE |
| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special | 4Web, Inc. | 02/12/2026SE |
| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)KWQ · Traditional | Alphatec Spine, Inc. | 08/28/2025SE |
| K251436 | Resolve Anterior Cervical Plate SystemKWQ · Abbreviated | Pioneer Surgical Technology, Inc. | 07/11/2025SE |
| K250446 | Frida Anterior Cervical Plate SystemKWQ · Traditional | Spineup, Inc. | 05/23/2025SE |
| K250602 | X-PAC® N-GAGE Lumbar Plate SystemKWQ · Traditional | Expanding Innovations, Inc. | 05/20/2025SE |
| K250486 | Skyway Anterior Cervical Plate SystemKWQ · Special | Kyocera Medical Technologies Inc. (KMTI) | 04/10/2025SE |
| K243904 | Elegance® Anterior Cervical plateKWQ · Special | Clariance | 01/14/2025SE |
| K243369 | Cervical Plating SystemKWQ · Traditional | Life Spine, Inc. | 12/11/2024SE |
| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…KWQ · Traditional | Stryker Spine | 11/07/2024SE |
| K243015 | Skyway Anterior Cervical Plate SystemKWQ · Traditional | Kyocera Medical Technologies, Inc. | 11/05/2024SE |
| K231251 | FlexWing Anterior Cervical Plate SystemKWQ · Traditional | Jeil Medical Corporation | 07/24/2024SE |
| K240592 | Wolff's Law Anterior Cervical Plate SystemKWQ · Traditional | Spinal Simplicity, LLC | 05/24/2024SE |
| K241175 | MiRus MoRe Lumbar Plating SystemKWQ · Traditional | MiRus, LLC | 05/17/2024SE |
| K240935 | ARENAL Anterior Cervical Plate SystemKWQ · Traditional | Effortmed, LLC | 05/17/2024SE |
| K233215 | icotec Anterior Cervical Plate SystemKWQ · Traditional | Icotec AG | 05/17/2024SE |
| K240484 | MSFX Mikron Cervical Anterior Plate SystemKWQ · Traditional | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 04/17/2024SE |
| K232256 | Alcantara Thoracolumbar Plate SystemKWQ · Traditional | Camber Spine Technologies, LLC | 04/16/2024SE |
| K240423 | TDM Anterior Cervical Plate SystemKWQ · Traditional | Tdm Co., Ltd. | 04/08/2024SE |
| K240690 | STRUXXURE® MCS Anterior Cervical Plate SystemKWQ · Special | Nexxt Spine | 03/22/2024SE |
| K240515 | uNion® MAX Cervical Plate SystemKWQ · Special | Ulrich Medical USA, Inc. | 03/18/2024SE |
| K233360 | Curiteva Thoracolumbar Plate SystemKWQ · Traditional | Curiteva, Inc. | 02/29/2024SE |
| K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…KWQ · Traditional | Alphatec Spine, Inc. | 02/22/2024SE |
| K231715 | MONDRIAN Anterior Lumbar Plate SystemKWQ · Traditional | Ctl Medical Corporation | 01/26/2024SE |
| K233735 | ADIRA Lateral Plate SystemKWQ · Traditional | Globus Medical, Inc. | 01/25/2024SE |
| K232318 | VICTORY Lumbar Plate SystemKWQ · Traditional | Globus Medical, Inc. | 10/31/2023SE |
| K231766 | Skyway Anterior Cervical Plate SystemKWQ · Traditional | Kyocera Medical Technologies Inc. (KMTI) | 09/12/2023SE |
| K231593 | Sapphire X3 Anterior Cervical Plate SystemKWQ · Traditional | Spinal Elements, Inc. | 08/02/2023SE |
| K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemKWQ · Special | L&K BIOMED Co., Ltd. | 07/19/2023SE |
| K231460 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…KWQ · Traditional | K&J Consulting Corp. | 07/16/2023SE |
| K230993 | CODA Anterior Cervical Plate SystemKWQ · Special | Pioneer Surgical Technology, Inc D.B.A Resolve… | 06/20/2023SE |
| K231090 | Zevo Anterior Cervical Plate SystemKWQ · Traditional | Medtronic Sofamor Danek USA, Inc. | 06/15/2023SE |
| K231145 | Axis Anterior Cervical Plate SystemKWQ · Traditional | Southern Medical (Pty) , Ltd. | 06/13/2023SE |
| K230721 | ATEC Lateral Plate SystemKWQ · Traditional | Alphatec Spine, Inc. | 05/09/2023SE |
| K230424 | Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral…KWQ · Traditional | Omnia Medical, LLC | 04/12/2023SE |
| K223753 | Cervical Plate SystemKWQ · Traditional | Double Medical Technology, Inc. | 03/14/2023SE |
| K223321 | Omnia Medical Coupler-C Anterior Cervical PlateKWQ · Traditional | Omnia Medical, LLC | 03/13/2023SE |
| K230301 | Athena III Cervical Plate SystemKWQ · Special | Medyssey USA, Inc. | 03/07/2023SE |
| K221053 | Magnes-C Anterior Cervical Plate SystemKWQ · Traditional | Fellowship of Orthopaedic Researchers, Inc. | 03/01/2023SE |
| K223627 | PreView-III Anterior Cervical Plate SystemKWQ · Traditional | Nexus Spine, LLC | 02/02/2023SE |
| K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemKWQ · Special | Aegis Spine, Inc. | 01/11/2023SE |
| K220843 | OAKTREE Anterior Lumbar Plate and Screw SystemKWQ · Traditional | Oak Tree Engineering, LLC | 12/07/2022SE |
| K222493 | CODA Anterior Cervical Plate SystemKWQ · Traditional | Pioneer Surgical Technology, Inc. | 11/18/2022SE |
| K222628 | Life Spine ALIF Buttress Plate SystemKWQ · Traditional | Life Spine, Inc. | 11/16/2022SE |
| K220334 | MONET Anterior Cervical Plate SystemKWQ · Traditional | Ctl Medical Corporation | 11/09/2022SE |
| K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior…KWQ · Traditional | Stryker Corporation | 10/19/2022SE |
| K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…KWQ · Traditional | Dio Medical Corporation | 10/18/2022SE |
| K220441 | CYGNUS MoRe Anterior Cervical Plate SystemKWQ · Traditional | MiRus, LLC | 09/16/2022SE |
| K221572 | VyPlate Anterior Cervical Plate SystemKWQ · Traditional | Vy Spine, LLC | 07/26/2022SE |
| K211718 | Venus Cervical Plate SystemKWQ · Traditional | Artfx Medical, LLC | 06/28/2022SE |
| K212527 | Cervical Spine Truss System Plating Solution (CSTS-PS)KWQ · Traditional | 4Web Medical, Inc. | 05/17/2022SE |
| K220182 | Aggeris-CKWQ · Traditional | Clariance | 03/30/2022SE |
| K213820 | BALTEUM - ONE Lumbar Plate SystemKWQ · Traditional | Huvexel Co. , Ltd. | 03/25/2022SE |
| K220275 | EMERGE Anterior Cervical Plate SystemKWQ · Traditional | Evolution Spine | 03/18/2022SE |
| K220324 | AccuFit Lateral 2-Hole PlateKWQ · Traditional | Precision Spine, Inc. | 03/16/2022SE |
| K220379 | IMPEACE and IMPEACE-Uni Anterior Cervical Plate SystemKWQ · Traditional | Medynus, Inc. | 03/03/2022SE |
| K220147 | Aspiron S ACP SystemKWQ · Special | U&I Corporation | 02/16/2022SE |
| K211712 | 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…KWQ · Traditional | Orthofix US, LLC | 02/11/2022SE |
| K213901 | Cyclops Anterior Cervical Plate SystemKWQ · Special | Degen Medical | 01/07/2022SE |
| K213219 | Vy Spine VyWasher Buttress SystemKWQ · Traditional | Vy Spine, LLC | 12/23/2021SE |
| K213456 | Xenco Medical Multilevel CerviKitKWQ · Traditional | Xenco Medical, LLC | 12/21/2021SE |
| K213443 | Insignia Anterior Cervical Plate SystemKWQ · Traditional | Alphatec Spine, Inc. | 12/15/2021SE |
| K212937 | Dakota ALIF Plate SystemKWQ · Traditional | Precision Spine, Inc. | 11/04/2021SE |
| K212446 | NuVasive Anterior Cervical Plate SystemsKWQ · Traditional | Nu Vasive, Incorporated | 11/03/2021SE |
| K210424 | Quantum Anterior Cervical PlateKWQ · Traditional | Nvision Biomedical Technologies, Inc. | 10/22/2021SE |
| K212405 | EMERGE Anterior Cervical Plate SystemKWQ · Abbreviated | Evolution Spine | 09/30/2021SE |
| K212139 | Admiral ACP SystemKWQ · Traditional | SeaSpine Orthopedics Corporation | 09/01/2021SE |
| K211903 | Shoreline Threaded TruProfile® PlateKWQ · Traditional | SeaSpine Orthopedics Corporation | 08/30/2021SE |
| K211205 | Prase-C Anterior Cervical Plate SystemKWQ · Traditional | Gbs Commonwealth Co., Ltd. | 08/12/2021SE |
| K211932 | Fixxsure Anterior Lumbar Plate and Screw SystemKWQ · Traditional | Oak Tree Engineering, LLC | 07/27/2021SE |
| K211408 | CervAlign® Anterior Cervical Plate SystemKWQ · Traditional | Pioneer Surgical Technology, Inc. | 06/23/2021SE |
| K210182 | PANAMA Anterior Cervical Plate (ACP) SystemKWQ · Traditional | Flospine | 04/07/2021SE |
| K210325 | APOLLO Anterior Cervical Plate (ACP) SystemKWQ · Traditional | Aurora Spine, Inc. | 03/23/2021SE |
| K210286 | Cure 2.0 Anterior Cervical Plate (ACP) SystemKWQ · Special | Meditech Spine, LLC | 03/18/2021SE |
| K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS)KWQ · Traditional | 4Web, Inc. | 03/10/2021SE |
| K202878 | Prase-AP Anterior Cervical Plate SystemKWQ · Traditional | Gbs Commonwealth Co., Ltd. | 01/29/2021SE |
| K203253 | NuVasive ACP SystemKWQ · Special | Nu Vasive, Incorporated | 12/03/2020SE |
| K202972 | Anterior Cervical Plate SystemKWQ · Traditional | Nutech Spine and Biologics | 11/24/2020SE |
| K203154 | KASILOF Cervical Plate SystemKWQ · Special | Kahtnu Surgical, Inc. | 11/05/2020SE |
| K202624 | Z-Span Plate SystemKWQ · Traditional | Zavation Medical Products, LLC | 11/04/2020SE |
| K201587 | icotec Anterior Cervical Plate SystemKWQ · Traditional | Icotec AG | 10/15/2020SE |
| K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…KWQ · Traditional | Zimmer Biomet Spine, Inc. | 10/08/2020SE |
| K202192 | STRUXXURE®-L and STRUXXURE®-A Plate SystemKWQ · Traditional | Nexxt Spine, LLC | 09/17/2020SE |
| K202227 | Artus cervical plate systemKWQ · Traditional | Ulrich GmbH & Co. KG | 09/14/2020SE |
| K202064 | Admiral ACP SystemKWQ · Traditional | SeaSpine Orthopedics Corporation | 08/26/2020SE |
| K201979 | Cervical Plate SystemKWQ · Traditional | Eminent Spine, LLC | 08/25/2020SE |
| K201521 | Medina Anterior Cervical Plate SystemKWQ · Traditional | Alliance Partners, LLC | 08/06/2020SE |
| K201079 | Aurora® Anterior Lumbar Plate SytstemKWQ · Traditional | Prism Surgical Design Pty , Ltd. | 08/05/2020SE |
| K192481 | AccelFix Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 07/28/2020SE |
| K200927 | Transept Cervical Plate SystemKWQ · Traditional | Neurostructures, Inc. | 07/24/2020SE |
| K201029 | Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemKWQ · Traditional | Spinal Elements, Inc. | 06/17/2020SE |
| K200883 | CarboClear® Cervical Plate SystemKWQ · Traditional | CarboFix Orthopedics , Ltd. | 06/04/2020SE |
| K200885 | Meridian Anterior Plate System, Regatta Lateral Plate SystemKWQ · Traditional | SeaSpine Orthopedics Corporation | 05/28/2020SE |
| K200995 | Insignia Anterior Cervical Plate SystemKWQ · Traditional | Alphatec Spine, Inc. | 05/21/2020SE |
| K200956 | NuVasive Thoracolumbar PlatesKWQ · Traditional | Nu Vasive, Incorporated | 05/21/2020SE |
| K201078 | NuVasive® ACP SystemKWQ · Special | Nu Vasive, Incorporated | 05/20/2020SE |
| K201136 | Cure Lumbar Plate SystemKWQ · Special | Meditech Spine, LLC | 05/12/2020SE |
| K200846 | Balteum Lumbar Plate SystemKWQ · Traditional | Huvexel Co. , Ltd. | 05/05/2020SE |
| K200523 | Biolign® Roto-Loc Cervical Plate SystemKWQ · Traditional | Elite Surgical Supplies (Pty), Ltd. | 04/30/2020SE |
| K193494 | Origin Anterior Cervical Plate SystemKWQ · Traditional | Orthopaedic & Spine Development | 04/06/2020SE |
| K200224 | SEA-LINK Anterior Cervical Plate SystemKWQ · Traditional | Indius Medical Technologies Pvt. , Ltd. | 03/24/2020SE |
| K200170 | SpineNet SSP SystemKWQ · Traditional | Spinenet, LLC | 02/05/2020SE |
| K192792 | TranS1 AxiaLIF Plus SystemKWQ · Traditional | Trans1 | 11/20/2019SE |
| K192049 | Oryx Cervical Plate SystemKWQ · Traditional | Innovasis, Inc. | 11/08/2019SE |
| K192494 | NexGen Anterior Cervical Plate SystemKWQ · Traditional | Precision Spine | 10/29/2019SE |
| K192678 | Genesys Spine Binary® Lumbar Plate SystemKWQ · Special | Genesys Spine | 10/24/2019SE |
| K192314 | RESONATE Anterior Cervical Plate SystemKWQ · Traditional | Globus Medical, Inc. | 10/23/2019SE |
| K191584 | FORTICO Anterior Cervical Fixation SystemKWQ · Traditional | Camber Spine Technologies, LLC | 10/22/2019SE |
| K191500 | NuVasive® ACP SystemKWQ · Traditional | Nu Vasive, Incorporated | 09/03/2019SE |
| K191786 | Cyclops Anterior Cervical Plate SystemKWQ · Traditional | Degen Medical, Inc. | 08/30/2019SE |
| K192076 | Binary® Anterior Cervical Plate SystemKWQ · Special | Genesys Spine | 08/29/2019SE |
| K190016 | Lateral Plate SystemKWQ · Traditional | Corelink, LLC | 06/12/2019SE |
| K190565 | Cervical PlateKWQ · Traditional | Eisertech, LLC | 05/31/2019SE |
| K183084 | Fuji Cervical Plate SystemKWQ · Special | Altus Partners, LLC | 05/29/2019SE |
| K190584 | CAYMAN LP Plate SystemKWQ · Traditional | K2m, Inc. | 05/15/2019SE |
| K190170 | MVP Cervical Plate SystemKWQ · Traditional | GS Medical Co., Ltd. | 05/13/2019SE |
| K190666 | CYGNUS Anterior Cervical Plate SystemKWQ · Traditional | MiRus, LLC | 05/09/2019SE |
| K190227 | Boomerang Anterior Cervical Plate SystemKWQ · Traditional | Choicespine, LP | 05/01/2019SE |
| K183056 | ASSURE® Anterior Cervical Plate SystemKWQ · Traditional | Globus Medical, Inc. | 04/19/2019SE |
| K190425 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | L&K BIOMED Co., Ltd. | 03/21/2019SE |
| K183409 | Athena II Cervical Plate SystemKWQ · Traditional | Medyssey USA, Inc. | 02/11/2019SE |
| K183073 | SMG Anterior Cervical Plate SystemKWQ · Traditional | Sapphire Medical Group | 02/11/2019SE |
| K182885 | Atlantis Anterior Cervical Plate, Divergence Anterior Cervical Fusion System, Premier…KWQ · Traditional | Medtronic Sofamor Danek USA, Inc. | 02/06/2019SE |
| K190053 | SECULOK ACP SystemKWQ · Special | U&I Corporation | 02/01/2019SE |
| K183060 | CervAlign Anterior Cervical Plate SystemKWQ · Traditional | Pioneer Surgical Technology, Inc. (Dba Rti… | 01/17/2019SE |
| K181190 | Pinehurst Anterior Cervical Plate SystemKWQ · Traditional | Signature Orthopaedics Pty, Ltd. | 01/17/2019SE |
| K182489 | 4CIS® Pinehurst Anterior Cervical Plate systemKWQ · Traditional | Solco Biomedical Co., Ltd. | 01/16/2019SE |
| K183214 | Raven Lumbar Plate SystemKWQ · Traditional | Choicespine, LP | 01/03/2019SE |
| K180772 | Met One Czar Anterior Cervical Plate SystemKWQ · Traditional | Met One Technologies | 12/17/2018SE |
| K182473 | PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…KWQ · Traditional | K2m, Inc. | 12/12/2018SE |
| K182418 | V3 Segmental Plating SystemKWQ · Traditional | Atlas Spine, Inc. | 11/29/2018SE |
| K182808 | Aspida® Anterior Lumbar Plating SystemKWQ · Traditional | Alphatec Spine, Inc. | 11/09/2018SE |
| K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…KWQ · Traditional | Globus Medical, Inc. | 11/06/2018SE |
| K182055 | SECULOK ACP SystemKWQ · Traditional | U&I Corporation | 09/10/2018SE |
| K181543 | Cure OPEL-C Plate SystemKWQ · Traditional | Meditech Spine, LLC | 08/31/2018SE |
| K181549 | Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate…KWQ · Traditional | Curiteva, LLC | 08/03/2018SE |
| K181562 | Curiteva Anterior Cervical Plate SystemKWQ · Traditional | Curiteva, LLC | 08/02/2018SE |
| K180022 | Athena Cervical Plate SystemKWQ · Traditional | Medyssey USA, Inc. | 07/20/2018SE |
| K181063 | Kestrel Buttress Plate SystemKWQ · Traditional | Innovasis, Inc. | 07/13/2018SE |
| K181244 | Zavation Cervical Plate SystemKWQ · Traditional | Zavation Medical Products, LLC | 07/10/2018SE |
| K180755 | Vail ALIF Buttress Plate SystemKWQ · Traditional | Evolution Spine, LLC | 07/06/2018SE |
| K180166 | Life Spine Lumbar Fixation System (SENTRY)KWQ · Traditional | Life Spine, Inc. | 06/22/2018SE |
| K180090 | Cure Lumbar Plate SystemKWQ · Special | Meditech Spine, LLC | 04/23/2018SE |
| K173935 | Mediant Anterior Cervical Plating SystemKWQ · Traditional | Intelligent Implant Systems, LLC | 04/16/2018SE |
| K173867 | Axis Anterior Cervical Plate SystemKWQ · Traditional | Axis Orthopaedics | 04/05/2018SE |
| K173885 | Genesys Spine Binary Lumbar Plate SystemKWQ · Traditional | Genesys Spine | 04/03/2018SE |
| K180537 | Zavation Buttress Plate SystemKWQ · Traditional | Zavation Medical Products, LLC | 03/27/2018SE |
| K171797 | TRYPTIK2 C-Plate Anterior Cervical Plate SystemKWQ · Traditional | Spineart | 02/26/2018SE |
| K173521 | SeaSpine Cabo ACP (Anterior Cervical Plate) SystemKWQ · Traditional | SeaSpine Orthopedics Corporation | 01/24/2018SE |
| K173306 | EZ PlateKWQ · Traditional | Zavation Medical Products, LLC | 01/22/2018SE |
| K173375 | Anterior Cervical Plate SystemKWQ · Traditional | Evolution Spine, LLC | 12/21/2017SE |
| K173091 | Boundary Anterior Lumbar Buttress PlateKWQ · Traditional | Nvision Biomedical Technologies, LLC | 12/06/2017SE |
| K173099 | Fortis and Hana Anterior Cervical Plate SystemKWQ · Traditional | Huvexel Co. , Ltd. | 11/30/2017SE |
| K172585 | Liberty Anterior Cervical PlateKWQ · Traditional | Valorus Spine | 10/23/2017SE |
| K163366 | Shanghai Sanyou CARMEN Cervical Fusion SystemKWQ · Traditional | Shanghai Sanyou Medical Co, Ltd. | 10/05/2017SE |
| K172086 | Matira Anterior Cervical SystemKWQ · Traditional | Kalitec Direct, LLC | 09/22/2017SE |
| K172131 | 2 Hole Lateral Plating SystemKWQ · Traditional | Life Spine, Inc. | 08/28/2017SE |
| K172104 | Ozark(tm) Cervical Plate SystemKWQ · Traditional | K2m, Inc. | 08/23/2017SE |
| K163625 | NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS…KWQ · Traditional | Signature Orthopaedics Pty, Ltd. | 08/11/2017SE |
| K171439 | EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate…KWQ · Traditional | Medos International SARL | 07/20/2017SE |
| K170224 | Spider Cervical Plating SystemKWQ · Traditional | X-Spine Systems, Inc. | 07/06/2017SE |
| K163104 | Terrace Anterior Cervical Plate SystemKWQ · Traditional | Corelink, LLC | 06/21/2017SE |
| K171538 | Cure Lumbar Plate SystemKWQ · Traditional | Meditech Spine, LLC | 06/16/2017SE |
| K171112 | Trifore(tm) Cervical Plating SystemKWQ · Traditional | Neurostructures, Inc. | 06/08/2017SE |
| K170342 | Ocata Anterior Cervical SystemKWQ · Traditional | Kalitec Direct, LLC | 05/09/2017SE |
| K170530 | Butrex Lumbar Buttress Plating SystemKWQ · Special | X-Spine Systems, Inc. | 03/22/2017SE |
| K162824 | Z-Span Plate SystemKWQ · Traditional | Zavation, LLC | 02/17/2017SE |
| K163602 | Kepler I Cervical Plate SystemKWQ · Traditional | Orbbo Surgical, LLC | 02/16/2017SE |
| K163061 | Altus Spine Cervical Plate SystemKWQ · Traditional | Altus Partners, LLC | 02/06/2017SE |
| K161641 | LOSPA IS ACP SystemKWQ · Traditional | Corentec Co., Ltd. | 01/05/2017SE |
| K160982 | SphynxKWQ · Traditional | Eden Spine, LLC | 12/22/2016SE |
| K162638 | CETRA Anterior Cervical Plate SystemKWQ · Traditional | Orthofix, Inc. | 12/16/2016SE |
| K162194 | MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemKWQ · Traditional | Medicrea International SA | 12/08/2016SE |
| K162211 | AccuFit Lateral Plate SystemKWQ · Traditional | Precision Spine, Inc. | 11/28/2016SE |
| K162250 | FortiBridge Anterior Cervical Plate SystemKWQ · Special | Nanovis Spine, LLC | 10/26/2016SE |
| K162664 | Pyrenees Cervical Plate SystemKWQ · Special | K2m, Inc. | 10/07/2016SE |
| K161524 | Tangis Anterior Cervical PlateKWQ · Traditional | Nvision Biomedical Technologies, LLC | 09/02/2016SE |
| K160702 | ZION Anterior Cervical Fixation SystemKWQ · Traditional | Astura Medical | 08/23/2016SE |
| K153097 | Belvedere Lateral Plating SystemKWQ · Traditional | Neurostructures, Inc. | 07/15/2016SE |
| K160604 | Cure Anterior Cervical Plate (ACP) SystemKWQ · Traditional | Meditech Spine, LLC | 07/01/2016SE |
| K153526 | Pyrenees Cervical Plate SystemKWQ · Traditional | K2m | 04/27/2016SE |
| K160522 | White Pearl Preferred Angle Anterior Cervical PlateKWQ · Traditional | Osseus Fusion Systems, LLC | 04/26/2016SE |
| K153042 | TRYPTIK2C-plate Anterior Cervical Plate SystemKWQ · Traditional | Spineart | 03/28/2016SE |
| K160362 | Z-Span Plate SystemKWQ · Traditional | Zavation, LLC | 03/22/2016SE |
| K151553 | Anterior Cervical Plate SystemKWQ · Traditional | Osteomed Implantes, Ltda | 02/10/2016SE |
| K152239 | Zero-P Natural Plate SystemKWQ · Traditional | Synthes (Usa), LLC | 12/02/2015SE |
| K152282 | Cam Lock Plating SystemKWQ · Traditional | Life Spine, Inc. | 11/20/2015SE |
| K152623 | ATLANTIS Anterior Cervical Plate SystemKWQ · Traditional | Medtronic Sofamor Danek USA, Inc. | 11/12/2015SE |
| K152455 | Amendia Cervical Plate SystemKWQ · Traditional | Amendia, Inc. | 10/15/2015SE |
| K152193 | Renovis Anterior Cervical Plate SystemKWQ · Traditional | Renovis Surgical Technologies, Inc. | 09/25/2015SE |
| K152281 | Pyrenees Cervical Plate SystemKWQ · Special | K2m | 09/24/2015SE |
| K152015 | Pyrenees Cervical Plate SystemKWQ · Traditional | K2m, Inc. | 09/04/2015SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1821-2026 Class II | Brand Name: Elegance Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL…Due to a quality issue regarding the presence of burr on the finished cervical plate product. | Clariance-SAS | 02/20/2026Open, Classified |
| Z-1827-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1826-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1825-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1824-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1823-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1822-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1821-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1820-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1819-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1818-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1817-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1816-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1815-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1814-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1813-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1812-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1811-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1810-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1809-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1808-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1807-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1806-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1805-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1804-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1803-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1802-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1801-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1800-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1799-2021 Class II | Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16…There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate… | Alphatec Spine, Inc. | 04/26/2021Terminated |
| Z-1244-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1243-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 22mm Material Number:…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1242-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 95mm Material Number:…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1241-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 90mm Material Number:…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1240-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 85mm Material Number:…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1239-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number:…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1238-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 75mm Material Number:…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1237-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number:…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1236-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 100mm Material Number:…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1235-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 88mm Material Number: 66-488…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1234-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Number: 66-484…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1233-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 80mm Material Number: 66-480…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1232-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1231-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number: 66-472…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1230-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm Material Number: 66-468…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1229-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number: 66-464…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1228-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1227-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1226-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |
| Z-1225-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | RTI Surgical, Inc. (dba Pioneer Surgical… | 01/15/2021Open, Classified |