MRW
- Product code
- MRW
- Device name
- System, Facet Screw Spinal Device
- Device class
- Class U
- Medical specialty
- Unknown
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 20
- Summaries archived here
- 19 (direct download)
- 510(k) clearances (all years, FDA)
- 78 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (20)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261209 | 2026-06-11 | SurGenTec, LLC | Ion-L | |
| K253676 | 2026-05-14 | Providence Medical Technology, Inc. | CORUS Posterior Cervical Stabilization System 3D (C | |
| K253432 | 2026-03-19 | Vy Spine, LLC | DiversiVy Facet Screw System | |
| K251714 | 2026-01-16 | SurGenTec, LLC | Ion-C | |
| K250679 | 2025-12-04 | Sc Medica | FFX Facet Fixation System | |
| K253190 | 2025-11-20 | Providence Medical Technology, Inc. | CORUS-LX Implant | |
| K252153 | 2025-10-16 | Sc Medica | FFX Facet Fixation System | |
| K251885 | 2025-07-10 | Providence Medical Technology, Inc. | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX | FDA |
| K250920 | 2025-05-22 | Arthrex, Inc. | Arthrex Spine Compression FT Screw | |
| K242527 | 2025-05-21 | Spinal Elements, Inc. | The Karma® Fixation System | |
| K243865 | 2025-03-24 | Aurora Spine | AERO MIS Facet Fusion System | |
| K243265 | 2024-12-04 | SurGenTec, LLC | Ion 3D | |
| K242650 | 2024-09-20 | Zygofix , Ltd. | zLOCK Lumbar Facet Fixation System | |
| K241035 | 2024-06-25 | Providence Medical Technology, Inc. | PMT Posterior Cervical Stabilization System (PCSS) | |
| K241416 | 2024-06-17 | SurGenTec, LLC | Ion 3D | |
| K232468 | 2024-05-09 | Sc Medica | SC Medica FFX | |
| K240085 | 2024-04-18 | Zygofix , Ltd. | zLOCK Lumbar Facet Fixation System | |
| K240086 | 2024-02-08 | SurGenTec, LLC | Ion 3D | |
| K230840 | 2023-12-19 | Providence Medical Technology, Inc. | PMT Facet Fixation System, Lumbar (PMT FFS-LX) | |
| K232877 | 2023-12-13 | K&J Consulting Corporation | FaSet Fixation System, UNITY Sacroiliac Joint Fixati |
Official FDA classification page: MRW
Classification and pathway per current FDA publications. Data from openFDA (CC0).