Product code MRW · Class U
System, Facet Screw Spinal Device
7510(k)s in 12 months (79 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in MRW
| Company | 510(k)s | Recalls |
|---|---|---|
| Providence Medical Technology, Inc. | 9 | 0 |
| SurGenTec, LLC | 6 | 0 |
| Interventional Spine, Inc. | 2 | 2 |
| Medtronic Sofamor Danek, Inc. | 3 | 1 |
| Nuvasive, Inc. | 4 | 0 |
| Triage Medical, Inc. | 4 | 0 |
| Globus Medical, Inc. | 3 | 0 |
| Sc Medica | 3 | 0 |
| Alphatec Spine, Inc. | 2 | 0 |
| Amendia, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 2026 | K262618 | Arthrex Spine Compression FT Screw Arthrex, Inc. | MRW |
| Jun 11, 2026 | K261209 | Ion-L SurGenTec, LLC | MRW |
| May 14, 2026 | K253676 | CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D) Providence Medical Technology, Inc. | MRW |
| Mar 19, 2026 | K253432 | DiversiVy Facet Screw System Vy Spine, LLC | MRW |
| Jan 16, 2026 | K251714 | Ion-C SurGenTec, LLC | MRW |
| Dec 4, 2025 | K250679 | FFX Facet Fixation System Sc Medica, FR | MRW |
| Nov 20, 2025 | K253190 | CORUS-LX Implant Providence Medical Technology, Inc. | MRW |
| Oct 16, 2025 | K252153 | FFX Facet Fixation System Sc Medica, FR | MRW |
| Jul 10, 2025 | K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant Providence Medical Technology, Inc. | MRW |
| May 22, 2025 | K250920 | Arthrex Spine Compression FT Screw Arthrex, Inc. | MRW |
| May 21, 2025 | K242527 | The Karma® Fixation System Spinal Elements, Inc. | MRW |
| Mar 24, 2025 | K243865 | AERO MIS Facet Fusion System Aurora Spine | MRW |
| Dec 4, 2024 | K243265 | Ion 3D SurGenTec, LLC | MRW |
| Sep 20, 2024 | K242650 | zLOCK Lumbar Facet Fixation System Zygofix , Ltd., IL | MRW |
| Jun 25, 2024 | K241035 | PMT Posterior Cervical Stabilization System (PCSS) Providence Medical Technology, Inc. | MRW |
| Jun 17, 2024 | K241416 | Ion 3D SurGenTec, LLC | MRW |
| May 9, 2024 | K232468 | SC Medica FFX Sc Medica, FR | MRW |
| Apr 18, 2024 | K240085 | zLOCK Lumbar Facet Fixation System Zygofix , Ltd., IL | MRW |
| Feb 8, 2024 | K240086 | Ion 3D SurGenTec, LLC | MRW |
| Dec 19, 2023 | K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX) Providence Medical Technology, Inc. | MRW |
| Dec 13, 2023 | K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C Stand Alo K&J Consulting Corporation | MRW |
| Aug 11, 2023 | K230297 | PMT Expandable Cage (PMT EXP) Providence Medical Technology, Inc. | MRW |
| Dec 9, 2022 | K220951 | PMT Facet Fixation System (PMT FFS) Providence Medical Technology, Inc. | MRW |
| Oct 5, 2022 | K222515 | FaSet Fixation System Dio Medical Corporation | MRW |
| Feb 25, 2022 | K211855 | Ion Facet Screw System SurGenTec, LLC | MRW |
| Dec 16, 2019 | K192744 | CORRIDOR Fixation System Globus Medical, Inc. | MRW |
| Nov 20, 2019 | K192281 | AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Medos International SARL, CH | MRW |
| Oct 11, 2019 | K183589 | PMT Facet Screw Providence Medical Technology, Inc. | MRW |
| Jun 28, 2018 | K180729 | FaSet Fixation System Huvexel Co. , Ltd., KR | MRW |
| Jan 3, 2018 | K173198 | Facet Screw Fixation System U&I Corporation, KR | MRW |
| Feb 16, 2017 | K163374 | ALLY Facet Screws Providence Medical Technology, Inc. | MRW |
| Aug 4, 2016 | K161798 | FacetBRIDGE® System Ldr Spine USA, Inc. | MRW |
| Jan 25, 2016 | K152137 | FacetBRIDGE System Ldr Spine USA | MRW |
| Apr 28, 2015 | K150223 | Facet-Link Stabilization Platform Facet-Link, Inc. | MRW |
| Jan 16, 2015 | K142980 | Proficient (TM) Facet Screw Spine System Spine Wave, Inc. | MRW |
| Nov 18, 2013 | K132859 | INTEGRA FACET FIXATION SYSTEM Seaspine, Inc. | MRW |
| Oct 28, 2013 | K132126 | SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM Spectrum Spine, LLC | MRW |
| Aug 9, 2013 | K130863 | FACET SCREW SYSTEM Spinal USA | MRW |
| Jul 12, 2013 | K131417 | FACET FIXX Nexxt Spine, LLC | MRW |
| May 3, 2013 | K120597 | KOMPREDA Custom Spine, Inc. | MRW |
| May 1, 2013 | K123932 | ZYGAFIX SPINAL FACET SCREW SYSTEM X-Spine Systems, Inc. | MRW |
| Feb 28, 2013 | K123497 | FACET SCREW SYSTEM Facet-Link, Inc. | MRW |
| Nov 28, 2012 | K123218 | ILLICO FS FACET FIXATION SYSTEM Alphatec Spine, Inc. | MRW |
| Oct 23, 2012 | K121551 | RESOLUTE FACET SCREW SYSTEM Neurostructures, LLC | MRW |
| Oct 19, 2012 | K120340 | VENUS FACET SCREW SYSTEM Apollo Spine, Inc. | MRW |
| Sep 20, 2012 | K121850 | Typhoon(TM) Facet Screw Fixation System Choicespine, LP | MRW |
| Dec 6, 2011 | K113011 | SPARTAN S3 FACET SYSTEM Amendia, Inc. | MRW |
| Nov 28, 2011 | K110170 | RAPTOR FACET FIXATION SYSTEM Alphatec Spine, Inc. | MRW |
| Nov 21, 2011 | K112097 | GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 Exactech, Inc. | MRW |
| Nov 15, 2010 | K101762 | VIPER F2 FACET FIXATION SYSTEM Depuy Spine, Inc. | MRW |
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