System, Facet Screw Spinal Device
FDA product code MRW · Unclassified · Orthopedic
78510(k) clearances
0PMA approvals
4recalls
Implantimplanted device
Manufacturers
- Providence Medical Technology, Inc. 9
- SurGenTec, LLC 6
- Nuvasive, Inc. 4
- Triage Medical, Inc. 4
- Globus Medical, Inc. 3
- Sc Medica 3
- Medtronic Sofamor Danek 3
- Trans1 Incorporated 2
- Zygofix , Ltd. 2
- Interventional Spine Inc 2
- Amendia, Inc. 2
- X-Spine Systems, Inc. 2
- Ldr Spine USA 2
- Facet-Link, Inc. 2
- Alphatec Spine, Inc. 2
- SpineFrontier, Inc. 1
- Sofamor Danek USA,Inc. 1
- Life Spine, Inc. 1
- Spineology, Inc. 1
- Vy Spine, LLC 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261209 | Ion-LMRW · Traditional | SurGenTec, LLC | 06/11/2026SE |
| K253676 | CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D)MRW · Traditional | Providence Medical Technology, Inc. | 05/14/2026SE |
| K253432 | DiversiVy Facet Screw SystemMRW · Traditional | Vy Spine, LLC | 03/19/2026SE |
| K251714 | Ion-CMRW · Traditional | SurGenTec, LLC | 01/16/2026SE |
| K250679 | FFX Facet Fixation SystemMRW · Traditional | Sc Medica | 12/04/2025SE |
| K253190 | CORUS-LX ImplantMRW · Traditional | Providence Medical Technology, Inc. | 11/20/2025SE |
| K252153 | FFX Facet Fixation SystemMRW · Traditional | Sc Medica | 10/16/2025SE |
| K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantMRW · Special | Providence Medical Technology, Inc. | 07/10/2025SE |
| K250920 | Arthrex Spine Compression FT ScrewMRW · Traditional | Arthrex, Inc. | 05/22/2025SE |
| K242527 | The Karma® Fixation SystemMRW · Traditional | Spinal Elements, Inc. | 05/21/2025SE |
| K243865 | AERO MIS Facet Fusion SystemMRW · Traditional | Aurora Spine | 03/24/2025SE |
| K243265 | Ion 3DMRW · Special | SurGenTec, LLC | 12/04/2024SE |
| K242650 | zLOCK Lumbar Facet Fixation SystemMRW · Special | Zygofix , Ltd. | 09/20/2024SE |
| K241035 | PMT Posterior Cervical Stabilization System (PCSS)MRW · Traditional | Providence Medical Technology, Inc. | 06/25/2024SE |
| K241416 | Ion 3DMRW · Special | SurGenTec, LLC | 06/17/2024SE |
| K232468 | SC Medica FFXMRW · Traditional | Sc Medica | 05/09/2024SE |
| K240085 | zLOCK Lumbar Facet Fixation SystemMRW · Traditional | Zygofix , Ltd. | 04/18/2024SE |
| K240086 | Ion 3DMRW · Special | SurGenTec, LLC | 02/08/2024SE |
| K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX)MRW · Traditional | Providence Medical Technology, Inc. | 12/19/2023SE |
| K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…MRW · Traditional | K&J Consulting Corporation | 12/13/2023SE |
| K230297 | PMT Expandable Cage (PMT EXP)MRW · Traditional | Providence Medical Technology, Inc. | 08/11/2023SE |
| K220951 | PMT Facet Fixation System (PMT FFS)MRW · Traditional | Providence Medical Technology, Inc. | 12/09/2022SE |
| K222515 | FaSet Fixation SystemMRW · Traditional | Dio Medical Corporation | 10/05/2022SE |
| K211855 | Ion Facet Screw SystemMRW · Traditional | SurGenTec, LLC | 02/25/2022SE |
| K192744 | CORRIDOR Fixation SystemMRW · Traditional | Globus Medical, Inc. | 12/16/2019SE |
| K192281 | AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…MRW · Traditional | Medos International SARL | 11/20/2019SE |
| K183589 | PMT Facet ScrewMRW · Traditional | Providence Medical Technology, Inc. | 10/11/2019SE |
| K180729 | FaSet Fixation SystemMRW · Traditional | Huvexel Co. , Ltd. | 06/28/2018SE |
| K173198 | Facet Screw Fixation SystemMRW · Traditional | U&I Corporation | 01/03/2018SE |
| K163374 | ALLY Facet ScrewsMRW · Traditional | Providence Medical Technology, Inc. | 02/16/2017SE |
| K161798 | FacetBRIDGE® SystemMRW · Special | Ldr Spine USA, Inc. | 08/04/2016SE |
| K152137 | FacetBRIDGE SystemMRW · Traditional | Ldr Spine USA | 01/25/2016SE |
| K150223 | Facet-Link Stabilization PlatformMRW · Traditional | Facet-Link, Inc. | 04/28/2015SE |
| K142980 | Proficient (TM) Facet Screw Spine SystemMRW · Traditional | Spine Wave, Inc. | 01/16/2015SE |
| K132859 | Integra Facet Fixation SystemMRW · Traditional | Seaspine, Inc. | 11/18/2013SE |
| K132126 | Spectrum Spine Fenestrated Facet Screw SystemMRW · Traditional | Spectrum Spine, LLC | 10/28/2013SE |
| K130863 | Facet Screw SystemMRW · Traditional | Spinal USA | 08/09/2013SE |
| K131417 | Facet FixxMRW · Traditional | Nexxt Spine, LLC | 07/12/2013SE |
| K120597 | KompredaMRW · Traditional | Custom Spine, Inc. | 05/03/2013SE |
| K123932 | Zygafix Spinal Facet Screw SystemMRW · Traditional | X-Spine Systems, Inc. | 05/01/2013SE |
| K123497 | Facet Screw SystemMRW · Traditional | Facet-Link, Inc. | 02/28/2013SE |
| K123218 | Illico FS Facet Fixation SystemMRW · Special | Alphatec Spine, Inc. | 11/28/2012SE |
| K121551 | Resolute Facet Screw SystemMRW · Traditional | Neurostructures, LLC | 10/23/2012SE |
| K120340 | Venus Facet Screw SystemMRW · Traditional | Apollo Spine, Inc. | 10/19/2012SE |
| K121850 | Typhoon(TM) Facet Screw Fixation SystemMRW · Traditional | Choicespine, LP | 09/20/2012SE |
| K113011 | Spartan S3 Facet SystemMRW · Special | Amendia, Inc. | 12/06/2011SE |
| K110170 | Raptor Facet Fixation SystemMRW · Traditional | Alphatec Spine, Inc. | 11/28/2011SE |
| K112097 | Gibralt Spine Systems Facet Screw 04.0,04.5MRW · Traditional | Exactech, Inc. | 11/21/2011SE |
| K101762 | Viper F2 Facet Fixation SystemMRW · Special | Depuy Spine, Inc. | 11/15/2010SE |
| K101765 | Kyphon Anchor Facet Screw SystemMRW · Traditional | Medtronic Spine, LLC | 10/22/2010SE |
| K102438 | Primalok Facet Fixation SystemMRW · Traditional | Osteomed LP | 09/30/2010SE |
| K101364 | Lanx Facet Screw SystemMRW · Traditional | Lanx, Inc. | 08/16/2010SE |
| K101284 | Facet Screw SystemMRW · Traditional | Nuvasive, Inc. | 07/15/2010SE |
| K100154 | Fixcet Spinal Facet Screw SystemMRW · Traditional | X-Spine Systems, Inc. | 05/21/2010SE |
| K092568 | Spartan S3 Facet SystemMRW · Traditional | Amendia, Inc. | 11/17/2009SE |
| K092464 | Spineology Facet ScrewMRW · Traditional | Spineology, Inc. | 11/09/2009SE |
| K090952 | Zyfuse Facet Fixation SystemMRW · Traditional | Globus Medical, Inc. | 07/14/2009SE |
| K090865 | Life Spine Facet Screw Spinal SystemMRW · Traditional | Life Spine | 06/26/2009SE |
| K090767 | Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerMRW · Special | Interventional Spine, Inc. | 06/11/2009SESU |
| K083442 | Corridor Fixation SystemMRW · Traditional | Globus Medical, Inc. | 02/06/2009SE |
| K082795 | Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantMRW · Traditional | Interventional Spine, Inc. | 12/12/2008SE |
| K073515 | TRANS1 Facet ScrewMRW · Traditional | Trans1 Incorporated | 03/11/2008SE |
| K071420 | Chameleon Fixation SystemMRW · Traditional | Spinefrontier, Inc. | 01/16/2008SE |
| K062391 | Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02…MRW · Traditional | Triage Medical, Inc. | 09/14/2006SE |
| K061041 | US Spine Facet Fixation SystemMRW · Traditional | Us Spine | 06/19/2006SE |
| K052043 | 3.8MM CS Facet Compression DeviceMRW · Traditional | Triage Medical, Inc. | 10/17/2005SE |
| K051856 | TRANS1 Facet ScrewsMRW · Traditional | Trans1 Incorporated | 09/26/2005SE |
| K051949 | 4.5 MM LS Facet Compression Device with Polymer Washer, Model LSPW-45-3040MRW · Special | Triage Medical, Inc. | 08/05/2005SE |
| K043351 | 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or NMRW · Traditional | Triage Medical, Inc. | 02/18/2005SE |
| K031657 | Stryker Spine Oasys Bone ScrewMRW · Traditional | Howmedica Osteonics Corp. | 08/22/2003SE |
| K021705 | Modification to Townley Transfacepedicular Screw Fixation SystemMRW · Special | Medtronic Sofamor Danek, Inc. | 07/24/2002SE |
| K020411 | Nuvasive Triad Facet Screw SystemMRW · Traditional | Nuvasive, Inc. | 03/12/2002SE |
| K013829 | Modification to Townley Transfacetpedicular Screw Fixation SystemMRW · Special | Medtronic Sofamor Danek, Inc. | 12/19/2001SE |
| K012773 | Discovery Facet Screw Fixation SystemMRW · Traditional | Depuyacromed | 11/16/2001SE |
| K003928 | Townley Transfacetpedicular Screw Fixation SystemMRW · Special | Medtronic Sofamor Danek, Inc. | 01/17/2001SE |
| K001323 | Nuvasive Percutaneous Transfacet/Intrapedicular ScrewMRW · Traditional | Nuvasive, Inc. | 07/25/2000SE |
| K994308 | Nuvasive Townley Facet ScrewMRW · Traditional | Nuvasive, Inc. | 04/18/2000SE |
| K953076 | Townley Facet/Pedicular Screw Plating SystemMRW · Traditional | Sofamor Danek USA,Inc. | 02/28/1997SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1797-2021 Class II | Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit…Product is impacted by a thread profile defect due to a manufacturing issue. | Medtronic Sofamor Danek USA, Inc | 04/27/2021Terminated |
| Z-0008-2012 | OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed…Two of the Implant Driver Assembly tips were reported to break during surgery. | Osteomed, Lp | 06/07/2011Terminated |
| Z-3034-2011 | Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile, canulated…This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the… | Interventional Spine Inc | 03/15/2011Terminated |
| Z-3033-2011 | PERPOS PLS, CATALOG #'s 9045-01 & 9045-02 A sterile, medical device kit consisting of…This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the… | Interventional Spine Inc | 03/15/2011Terminated |