Intervertebral Fusion Device With Bone Graft, Cervical
FDA product code ODP · Class II (moderate risk) · 21 CFR 888.3080 · Orthopedic
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
354510(k) clearances
0PMA approvals
11recalls
Implantimplanted device
Manufacturers
- Orthofix Srl 10
- Nu Vasive, Incorporated 8
- Medtronic Sofamor Danek USA, Inc. 8
- Globus Medical, Inc. 7
- Gbs Commonwealth Co., Ltd. 7
- Stryker Spine 6
- Spineart 6
- Reliance Medical Systems, LLC 6
- Innovasis, Inc. 5
- L&K BIOMED Co., Ltd. 5
- Vy Spine, LLC 5
- Nanovis, LLC 4
- Tyber Medical, LLC 4
- X-Spine Systems, Inc. 4
- Wenzel Spine, Inc. 4
- Ctl Medical Corporation 4
- Nvision Biomedical Technologies, Inc. 4
- Alphatec Spine, Inc. 4
- Xenco Medical, LLC 4
- SpineFrontier, Inc. 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion SystemODP · Special | Wenzel Spine, Inc. | 08/26/2026SE |
| K262489 | BluEX Cervical Expandable Cage SystemODP · Special | L&K BIOMED Co., Ltd. | 08/18/2026SE |
| K253041 | 3d Cage CervicalODP · Traditional | Fims Co., Ltd. | 07/23/2026SE |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special | Stryker Spine | 07/17/2026SE |
| K254130 | C.A. Medical Interbody Fusion SystemODP · Special | C.A. Medical, LLC | 07/08/2026SE |
| K260840 | BluEX Cervical Expandable Cage SystemODP · Traditional | L&K BIOMED Co., Ltd. | 05/16/2026SE |
| K260850 | Osteomni Spinal Cages SystemODP · Traditional | Osteomni, Inc. | 05/12/2026SE |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special | Zsfab, Inc. | 04/24/2026SE |
| K253260 | ORIO-3D Cage SystemODP · Traditional | SpineCraft | 04/16/2026SE |
| K260340 | HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional | HC Biologics, LLC | 04/13/2026SE |
| K242303 | Mod-CODP · Traditional | Orthomod, LLC | 04/01/2026SE |
| K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemODP · Traditional | Spectrum Spine | 03/30/2026SE |
| K252432 | Flex-Z Cervical CageODP · Traditional | Spinepoint, LLC | 03/25/2026SE |
| K254105 | Hive Standalone Cervical System and Hive C Interbody SystemODP · Traditional | NanoHive Medical, LLC | 02/13/2026SE |
| K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…ODP · Traditional | Curiteva, Inc. | 01/16/2026SE |
| K254061 | Curiteva Porous PEEK Cervical Interbody Fusion SystemODP · Special | Curiteva, Inc. | 01/15/2026SE |
| K252219 | Cervical Interbody and VBR Fusion SystemODP · Traditional | Sync Surgical | 01/14/2026SE |
| K252711 | Advantage-C Ti3D Cervical Interbody Fusion DeviceODP · Traditional | Intelivation Technologies | 01/08/2026SE |
| K252894 | aprevo® cervical interbody systemODP · Traditional | Carlsmed, Inc. | 01/06/2026SE |
| K252781 | MSFX Mikron PEEK CagesODP · Traditional | Mikron Makina Sanayi VE Tic. Ltd. Sti. | 12/19/2025SE |
| K250764 | SpineLinc Anterior Cervical Implant SystemODP · Traditional | Lincotek Medical | 12/05/2025SE |
| K250769 | Dakota LP SystemODP · Traditional | Precision Spine, Inc. | 11/24/2025SE |
| K252686 | EffortMed PEEK Cages & Corpectomy CagesODP · Traditional | Effortmed, LLC | 11/21/2025SE |
| K250560 | Bee HaODP · Traditional | NGMedical GmbH | 11/21/2025SE |
| K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemODP · Traditional | Degen Medical | 10/10/2025SE |
| K250335 | IVA & AEON Cervical and Lumbar Cage SystemODP · Traditional | K&J Consulting | 08/29/2025SE |
| K251080 | IdentiTi II Cervical Interbody SystemODP · Traditional | Alphatec Spine, Inc. | 07/03/2025SE |
| K250605 | EVOL® ha Hyper C Cervical Interbody Fusion SystemODP · Special | Cutting Edge Spine, LLC | 03/12/2025SE |
| K243915 | FIX-C 3D Ti ACIF SystemODP · Traditional | Jeil Medical Corporation | 02/18/2025SE |
| K243673 | Xenco Medical CancelleX Cervical Interbody SystemODP · Traditional | Xenco Medical, LLC | 01/29/2025SE |
| K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMODP · Traditional | Carlsmed, Inc. | 11/15/2024SE |
| K242734 | ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemODP · Traditional | Zsfab | 11/07/2024SE |
| K242195 | Gemini Cervical Fusion Cage SystemODP · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 11/04/2024SE |
| K241738 | PYXIS 3D Titanium Cervical Cage systemODP · Traditional | GS Medical Co., Ltd. | 08/20/2024SE |
| K240893 | ARTFX MEDICAL Cervical PEEK CagesODP · Traditional | Artfx Medical | 06/28/2024SE |
| K240838 | Spectrum Spine Cervical Cage SystemODP · Traditional | Spectrum Spine, Inc. | 05/30/2024SE |
| K241396 | uCerv Flux-C 3D Porous Titanium Cervical InterbodyODP · Special | Ulrich Medical USA, Inc. | 05/23/2024SE |
| K232619 | MATRIX HA PEEK Cervical IBF SystemODP · Special | Sapphire Medical Group | 03/19/2024SE |
| K240416 | Tranquil-C Interbody SystemODP · Special | Nexus Spine, LLC | 03/12/2024SE |
| K231371 | BEE Cervical CageODP · Traditional | NGMedical GmbH | 01/12/2024SE |
| K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…ODP · Special | Gbs Commonwealth Co., Ltd. | 12/20/2023SE |
| K230639 | Align Cervical Interbody Fusion SystemODP · Traditional | Acuity Surgical Devices, LLC | 12/01/2023SE |
| K233084 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…ODP · Traditional | Gbs Commonwealth Co., Ltd. | 11/21/2023SE |
| K231836 | ClariVy Cervical IBF SystemODP · Traditional | Vy Spine, LLC | 10/30/2023SE |
| K230478 | Acro Composites Interbody SystemODP · Traditional | Acro Composites, LLC | 10/19/2023SE |
| K231899 | HAtetracell-C Titanium Cervical IBF SystemODP · Traditional | Innovasis, Inc. | 10/17/2023SE |
| K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…ODP · Special | Gbs Commonwealth Co., Ltd. | 10/13/2023SE |
| K231076 | VariLift®-C Interbody Fusion SystemODP · Traditional | Wenzel Spine, Inc. | 09/27/2023SE |
| K222988 | neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalODP · Traditional | Ht Medical D.B.A. Xenix Medical | 09/01/2023SE |
| K232150 | ZSFab Cervical Interbody SystemODP · Special | Zsfab, Inc. | 08/18/2023SE |
| K230607 | SPICCA Cervical Fusion CagesODP · Traditional | Southern Medical (Pty) , Ltd. | 08/14/2023SE |
| K222874 | CarboClear Cervical Cage System, CarboClear Cervical VBR SystemODP · Traditional | Carbofix Orthpedics , Ltd. | 07/26/2023SE |
| K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…ODP · Special | Nu Vasive, Incorporated | 07/11/2023SE |
| K222015 | Integral Titanium Cervical InterbodyODP · Traditional | Nvision Biomedical Technologies, Inc. | 07/05/2023SE |
| K230329 | F3D Interbody SystemODP · Traditional | Corelink, LLC | 06/06/2023SE |
| K230936 | Anatomic PEEK Cervical Fusion System with NanotechnologyODP · Traditional | Nanovis, LLC | 06/02/2023SE |
| K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…ODP · Traditional | Gbs Commonwealth Co., Ltd. | 05/22/2023SE |
| K222833 | Ventana C Spinal SystemODP · Traditional | Spinal Elements, Inc. | 05/19/2023SE |
| K230414 | ClariVy Cervical IBF SystemODP · Special | Vy Spine, LLC | 05/12/2023SE |
| K222004 | INTEGRATE -C Interbody Fusion SystemODP · Traditional | Happe Spine | 04/28/2023SE |
| K220513 | NITRO Interbody Fusion Cage System FamilyODP · Traditional | Ctl Medical Corporation | 04/25/2023SE |
| K220261 | NEST-C Interbody SystemODP · Traditional | Paonan Biotech Co., Ltd. | 04/24/2023SE |
| K223513 | UniVy OsteoVy-Ti Cervical IBF SystemODP · Special | Vy Spine, LLC | 04/18/2023SE |
| K230026 | SqualeODP · Traditional | Implanet, S.A. | 03/28/2023SE |
| K230583 | Tryptik TiODP · Special | Spineart SA | 03/22/2023SE |
| K223043 | The Integrity Spine Core SystemODP · Traditional | Integrity Spine | 03/20/2023SE |
| K223231 | Ti-Largo Cervical Interbody SystemODP · Traditional | Flospine | 02/24/2023SE |
| K213755 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…ODP · Traditional | Gbs Commonwealth Co., Ltd. | 02/17/2023SE |
| K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…ODP · Traditional | Stryker Spine | 02/14/2023SE |
| K213030 | Curiteva Porous PEEK Cervical Interbody Fusion SystemODP · Traditional | Curiteva, Inc. | 02/13/2023SE |
| K212701 | Eminent Spine 3D Cervical Interbody Fusion SystemODP · Traditional | Eminent Spine | 02/06/2023SE |
| K220296 | Manta Ray TDF SpacerODP · Traditional | SeaSpine Orthopedics Corporation | 02/03/2023SE |
| K223731 | NuVasive Modulus-C Interbody SystemODP · Special | Nuvasive, Inc. | 01/12/2023SE |
| K221266 | Cervical Spine Truss System (CSTS) Interbody Fusion DeviceODP · Traditional | 4Web Medical, Inc. | 01/05/2023SE |
| K222806 | Kodiak C Spinal Implant SystemODP · Traditional | Met One Technologies, LLC | 12/22/2022SE |
| K223510 | Matrix HA Fusion Porous Cervical IBF SystemODP · Special | Innovasis, Inc. | 12/12/2022SE |
| K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…ODP · Traditional | Alphatec Spine, Inc. | 11/17/2022SE |
| K221162 | UniVy OsteoVy Cervical IBF SystemODP · Traditional | Vy Spine, LLC | 11/04/2022SE |
| K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…ODP · Traditional | Globus Medical, Inc. | 10/21/2022SE |
| K222276 | CONDUIT Cages; FIBERGRAFT BG PuttyODP · Traditional | Depuy Spine | 10/15/2022SE |
| K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemODP · Traditional | Innovasis, Inc. | 08/26/2022SE |
| K220696 | uCerv Flux-C 3D Porous Titanium Cervical InterbodyODP · Traditional | Ulrich Medical USA | 08/19/2022SE |
| K212450 | Keos Anterior Cervical Interbody Fusion Device SystemODP · Traditional | Keos | 06/06/2022SE |
| K202266 | Reliance Cervical IBF SystemODP · Traditional | Reliance Medical Systems, LLC | 03/29/2022SE |
| K213980 | Peridot Spinal Interbody SystemODP · Traditional | Gbs Commonwealth Co., Ltd. | 03/15/2022SE |
| K213493 | Fortilink with TiPlus TechnologyODP · Traditional | Paradigm Spine | 01/27/2022SE |
| K212266 | FIX-C PEEK Anterior Cervical Interbody SystemODP · Traditional | Jeil Medical Corporation | 12/21/2021SE |
| K212715 | Vy Spine ClariVy Cervical IBF SystemODP · Traditional | Vy Spine, LLC | 12/20/2021SE |
| K213115 | CHENA-C Spacer SystemODP · Special | Kahtnu Surgical, Inc. | 12/06/2021SE |
| K211935 | ORIO-Ti Intervertebral Body Fusion Cage SystemODP · Traditional | Spinecraft, LLC | 09/30/2021SE |
| K212792 | Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK CageODP · Traditional | Medynus, Inc. | 09/23/2021SE |
| K201793 | EDEN Peek CageODP · Traditional | Jmt Co., Ltd. | 09/13/2021SE |
| K211704 | CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…ODP · Traditional | Orthofix, Inc. | 08/31/2021SE |
| K212038 | K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK CageODP · Traditional | K&J Consulting Corporation | 08/27/2021SE |
| K211501 | Advantage-C PEEK Cervical lnterbody Fusion DeviceODP · Traditional | Lntelivation, LLC | 08/24/2021SE |
| K210521 | DEXA-C Cervical Interbody SystemODP · Traditional | Aurora Spine, Inc. | 08/02/2021SE |
| K210890 | GPS Cervical SpacersODP · Special | G Surgical, LLC | 04/23/2021SE |
| K203520 | Blustone Synergy Interbody Fusion SystemODP · Traditional | Blustone Synergy, LLC | 04/07/2021SE |
| K203444 | BEE HA CageODP · Traditional | NGMedical GmbH | 03/18/2021SE |
| K203342 | CONSTRUX Mini Ti Spacer SystemODP · Traditional | Orthofix, Inc. | 03/18/2021SE |
| K202872 | Prase PEEK Anterior Cervical Interbody SpacerODP · Traditional | Gbs Commonwealth Co., Ltd. | 02/04/2021SE |
| K202398 | Ti3Z Cervical Interbody SystemODP · Traditional | Zavation Medical Products, LLC | 01/29/2021SE |
| K200429 | BEE CagesODP · Traditional | NGMedical GmbH | 01/29/2021SE |
| K202488 | ZSFab Cervical Interbody SystemODP · Traditional | Zsfab, Inc. | 01/07/2021SE |
| K200458 | Tailored-C Cervical Interbody Fusion SystemODP · Traditional | Bespoke Technologies | 12/28/2020SE |
| K201643 | ChoiceSpine Tiger Shark Cervical Spacer SystemODP · Traditional | Choice Spine, LLC | 12/22/2020SE |
| K200549 | Lucero Medical Cervical Cage SystemODP · Traditional | Lucero Medical, LLC | 12/16/2020SE |
| K202302 | Atlas Spine Rebar (Ti) Spacer SystemODP · Traditional | Atlas Spine, Inc. | 10/30/2020SE |
| K202949 | CONSTRUX Mini PEEK Spacer SystemODP · Special | Orthofix, Inc. | 10/29/2020SE |
| K202666 | CONSTRUX Mini PTC Spacer SystemODP · Special | Orthofix, Inc. | 10/14/2020SE |
| K201506 | Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…ODP · Special | Meditech Spine, LLC | 09/11/2020SE |
| K201769 | Cavetto [MAX] Cervical Cage SystemODP · Traditional | Neurostructures, Inc. | 09/03/2020SE |
| K200592 | GS Medical AnyPlus PEEK Cage SystemODP · Traditional | GS Medical Co., Ltd. | 08/10/2020SE |
| K200685 | RIGEL 3DR Anterior Cervical Interbody Fusion SystemODP · Traditional | MiRus, LLC | 06/11/2020SE |
| K200052 | CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemODP · Traditional | Orthofix, Inc. | 04/09/2020SE |
| K200312 | Tryptik TiODP · Traditional | Spineart | 04/06/2020SE |
| K192897 | icotec Cervical CageODP · Traditional | Icotec AG | 03/20/2020SE |
| K193359 | SureMAX Family of Cervical SpacersODP · Special | Additive Implants, Inc. | 01/03/2020SE |
| K192044 | 4CIS Marlin PEEK ACIF CageODP · Traditional | Solco Biomedical Co., Ltd. | 12/19/2019SE |
| K191812 | ADI Cervical Interbody Fusion DeviceODP · Traditional | Additive Device, Inc. (Adi) D/B/A Restor3D | 10/24/2019SE |
| K192316 | Matrix HA PEEK Cervical Implant SystemODP · Special | Sapphire Medical Group | 10/17/2019SE |
| K191822 | Nano FortiCore, FortiCoreODP · Traditional | Nanovis, LLC | 10/11/2019SE |
| K192208 | CORNICE Cervical Spacer SystemODP · Traditional | Legend Spine Technologies | 10/09/2019SE |
| K191537 | eCarbon IBDsODP · Traditional | Back 2 Basics Direct, LLC | 09/26/2019SE |
| K191243 | HEDRON Cervical SpacersODP · Traditional | Globus Medical, Inc. | 09/17/2019SE |
| K191354 | Ti3Z Cervical Interbody SystemODP · Traditional | Zavation Medical Products, LLC | 09/09/2019SE |
| K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…ODP · Special | Titan Spine, Inc. | 08/16/2019SE |
| K191621 | ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…ODP · Special | Choice Spine, LLC | 08/15/2019SE |
| K190291 | Addivation Medical Cervical Interbody SystemODP · Traditional | Addivation Medical, LLC | 07/30/2019SE |
| K190889 | Republic Spine Restore Cervical Interbody Fusion SystemODP · Traditional | Republic Spine, LLC | 06/19/2019SE |
| K182608 | Oyster ACIF CageODP · Traditional | Silony Medical GmbH | 06/13/2019SE |
| K190618 | RIGEL PEEK Anterior Cervical Interbody Fusion SystemODP · Traditional | MiRus, LLC | 06/06/2019SE |
| K190380 | nvcODP · Special | Nvision Biomedical Technologies, Inc. | 03/21/2019SE |
| K183397 | ChoiceSpine Stealth Cervical Spacer SystemODP · Special | Choicespine, LP | 03/06/2019SE |
| K190322 | SCARLET® AC-T Secured Anterior Cervical CageODP · Special | Spineart | 03/04/2019SE |
| K183083 | Shoreline Cervical Interbody RT SystemODP · Traditional | SeaSpine Orthopedics Corporation | 02/14/2019SE |
| K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…ODP · Special | Titan Spine, Inc. | 02/11/2019SE |
| K190067 | Velofix Interbody Fusion SystemODP · Special | U&I Corporation | 02/04/2019SE |
| K182477 | Cervical SpacerODP · Traditional | Additive Implants, LLC | 01/28/2019SE |
| K182284 | Tyber Medical PT Interbody SpacerODP · Traditional | Tyber Medical, LLC | 01/18/2019SE |
| K180909 | REVEL SpacersODP · Traditional | Globus Medical, Inc. | 12/18/2018SE |
| K181140 | Axis Chena Cervical PEEK Spacer SystemODP · Traditional | Axis Orthopaedics | 11/16/2018SE |
| K181590 | Neurostructures Cavetto® [MAX] Cervical Cage SystemODP · Special | Neurostructures, Inc. | 11/08/2018SE |
| K181229 | TirboLOX-C Cervical IBFDODP · Traditional | Captiva Spine, Inc. | 09/19/2018SE |
| K181471 | ACCUFUSE Cervical SystemODP · Traditional | Absolute Advantage Medical, LLC | 08/29/2018SE |
| K181435 | ATEC Cervical Spacer SystemODP · Traditional | Alphatec Spine, Inc. | 08/21/2018SE |
| K181115 | CxHA PEEK Cervical IBF SystemODP · Traditional | Innovasis, Inc. | 07/16/2018SE |
| K181261 | Curiteva Cervical Interbody Fusion SystemODP · Traditional | Curiteva, LLC | 07/09/2018SE |
| K180590 | Tyber Medical PT Interbody Spacer SystemODP · Traditional | Tyber Medical, LLC | 07/06/2018SE |
| K180364 | HD LifeSciences Cervical IBFD SystemODP · Traditional | Hd Lifesciences, LLC | 06/27/2018SE |
| K180674 | EVOL® ha-C Cervical Interbody Fusion SystemODP · Traditional | Cutting Edge Spine, LLC | 06/25/2018SE |
| K172788 | MONET Anterior Cervical Interbody Fusion Cage SystemODP · Traditional | Ctl Medical Corporation | 06/25/2018SE |
| K180401 | TiWAVE-C Porous Titanium Cervical CageODP · Traditional | Kalitec Direct, LLC | 06/14/2018SE |
| K180675 | Atlas Spine Expandable Cervical Interbody SystemODP · Traditional | Atlas Spine, Inc. | 06/13/2018SE |
| K173722 | PATRIOT COLONIAL Spacer, SUSTAIN SpacerODP · Traditional | Globus Medical, Inc. | 05/23/2018SE |
| K173832 | InTice-C Porous Ti Cervical Interbody SystemODP · Traditional | X-Spine Systems, Inc. | 05/17/2018SE |
| K172480 | icotec Interbody Cage SystemODP · Traditional | Icotec AG | 05/17/2018SE |
| K172568 | CervageODP · Traditional | Precifit Medical, Ltd. | 05/04/2018SE |
| K173128 | Alamo® CODP · Traditional | Alliance Partners, LLC | 03/22/2018SE |
| K173453 | Valeo® C+CSC with Lumen Interbody Fusion DeviceODP · Traditional | Amedica Corp. | 03/05/2018SE |
| K173324 | ALTA Anterior Cervical Interbody SpacerODP · Traditional | Astura Medical | 02/27/2018SE |
| K172320 | Neurostructures Cavetto® Cervical Cage SystemODP · Traditional | Neurostructures, Inc. | 02/26/2018SE |
| K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…ODP · Special | Titan Spine, LLC | 02/13/2018SE |
| K172212 | MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEKODP · Traditional | Ctl Medical Corporation | 01/09/2018SE |
| K173159 | Cervical Spinal Truss System (CSTS) Interbody Fusion DeviceODP · Traditional | 4Web, Inc. | 01/08/2018SE |
| K173102 | Reliance Cervical IBF SystemODP · Special | Reliance Medical Systems, LLC | 12/29/2017SE |
| K172926 | SeaSpine Vu cPOD, Zuma-C, Complete CervicalODP · Traditional | SeaSpine Orthopedics Corporation | 12/21/2017SE |
| K172185 | Tyber Medical PT Interbody Spacer SystemODP · Traditional | Tyber Medical, LLC | 12/21/2017SE |
| K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…ODP · Traditional | Globus Medical, Inc. | 12/20/2017SE |
| K172676 | NuVasive® Modulus-C Interbody SystemODP · Traditional | Nu Vasive, Incorporated | 12/14/2017SE |
| K173148 | AcifODP · Traditional | Coligne AG | 12/01/2017SE |
| K173030 | Vertera Spine Cohere Cervical Interbody Fusion DeviceODP · Traditional | Nu Vasive, Incorporated | 11/21/2017SE |
| K172253 | Altus Spine Cervical Interbody Fusion SystemODP · Traditional | Altus Partners, LLC | 11/21/2017SE |
| K172446 | SPIRA-C Open Matrix Cervical InterbodyODP · Traditional | Camber Spine Technologies | 11/07/2017SE |
| K172674 | Sapphire Cervical Implant SystemODP · Special | Sapphire Medical Group | 11/02/2017SE |
| K172437 | CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemODP · Special | Orthofix, Inc. | 11/02/2017SE |
| K172065 | Scarlet Ac-TODP · Traditional | Spineart | 09/29/2017SE |
| K172587 | Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersODP · Special | Medacta International S.A. | 09/18/2017SE |
| K163422 | Shanghai Sanyou PEEK Cage SystemODP · Traditional | Shanghai Sanyou Medical Co, Ltd. | 09/18/2017SE |
| K172489 | Reliance Cervical IBF SystemODP · Special | Reliance Medical Systems, LLC | 09/07/2017SE |
| K171496 | Tritanium C Anterior Cervical CageODP · Traditional | Stryker Spine | 09/06/2017SE |
| K171140 | Matrixx SystemODP · Traditional | Nexxt Spine, LLC | 08/22/2017SE |
| K171075 | Calix-C Cervical Interbody SpacerODP · Traditional | X-Spine Systems, Inc. | 08/01/2017SE |
| K171749 | Velofix(tm) Interbody Fusion SystemODP · Traditional | U&I Corporation | 07/13/2017SE |
| K170550 | Coveris Cervical Cage SystemODP · Traditional | Camber Spine Technologies | 07/13/2017SE |
| K170318 | NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyODP · Traditional | Ht Medical, LLC | 07/12/2017SE |
| K171046 | SeaSpine Cambria SystemODP · Traditional | SeaSpine Orthopedics Corporation | 07/07/2017SE |
| K170844 | Gemini-C Hybrid Cervical Interbody SystemODP · Traditional | Osseus Fusion Systems, LLC | 07/03/2017SE |
| K163494 | Summit Spine Channel Cervical Interbody Fusion SystemODP · Traditional | Summit Spine | 06/20/2017SE |
| K162682 | MATISSE Anterior Cervical Interbody Fusion Cage SystemODP · Traditional | Ctl Medical Corporation | 06/01/2017SE |
| K163673 | Fortilink-C with TETRAfuse 3D TechnologyODP · Traditional | Rti Surgical, Inc. | 05/23/2017SE |
| K162496 | Foundation 3D InterbodyODP · Traditional | Corelink, LLC | 05/04/2017SE |
| K163265 | Kepler IIODP · Traditional | Orbbo Surgical, LLC | 04/07/2017SE |
| K163491 | NuVasive CoRoent Small Interbody SystemODP · Traditional | Nu Vasive, Incorporated | 03/24/2017SE |
| K162402 | 4CIS® Marlin ACIF Cage SystemODP · Traditional | Solco Biomedical Co., Ltd. | 02/16/2017SE |
| K162587 | Roccia® AcifODP · Traditional | Silony Medical GmbH | 01/26/2017SE |
| K170074 | nvcODP · Special | Nvision Biomedical Technologies, LLC | 01/24/2017SE |
| K162694 | Ayers Rock Cervical interbody fusion systemODP · Traditional | Spineway | 01/12/2017SE |
| K161127 | The Small PLATEAU (PLATEAU-C) Spacer SystemODP · Traditional | Life Spine, Inc. | 12/22/2016SE |
| K162003 | IMSE Cervical CageODP · Traditional | The Institute of Musculoskeletal Science &… | 12/21/2016SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0896-2026 Class III | Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer…Labeling contains claims that are not consistently present. | Orthofix U.S. LLC | 11/03/2025Open, Classified |
| Z-0891-2026 Class III | Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer…Labeling contains claims that are not consistently present. | Orthofix U.S. LLC | 11/03/2025Open, Classified |
| Z-2462-2023 Class II | IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | Medicrea International | 07/12/2023Open, Classified |
| Z-2460-2023 Class II | IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | Medicrea International | 07/12/2023Open, Classified |
| Z-2456-2023 Class II | IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… | Medicrea International | 07/12/2023Open, Classified |
| Z-0429-2021 Class III | XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single…Cervical Implants contain a label that incorrectly identifies the grade of titanium used. | XTANT Medical | 09/30/2020Terminated |
| Z-0627-2014 Class II | C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless…As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm… | RTI Surgical, Inc. | 10/07/2013Terminated |
| Z-2103-2013 Class II | SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona…The recall decision has been made because because it has recently been determined that the instructions for… | SpineNet | 02/05/2013Terminated |
| Z-2120-2012 Class II | Octane-C Cervical, 6 Lordotic Intended for anterior cervical spine intervertebral body…Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe… | Exactech, Inc. | 06/15/2012Terminated |
| Z-0104-2012 | Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody…LABELING CORRECTION - Following review of labeling and promotional materials associated with the Zero-P… | Synthes USA (HQ), Inc. | 09/23/2011Terminated |
| Z-1348-2009 | Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use…Tip breakage, due to inadequate instructions for use. The Technique Guide provided incorrect information… | Synthes Spine | 02/10/2009Terminated |