MRW · System, Facet Screw Spinal Device
· Class U
Overview
| Product Code | MRW |
|---|---|
| Device Name | System, Facet Screw Spinal Device |
| Device Class | Class U |
| Review Panel | |
| Implant | Yes |
Recent Cleared Devices (20 of 77)
Showing 20 most recent of 77 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253676 | CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) | Providence Medical Technology, Inc. | May 14, 2026 | SESE |
| K253432 | DiversiVy™ Facet Screw System | Vy Spine, LLC | Mar 19, 2026 | SESE |
| K251714 | Ion-C | SurGenTec, LLC | Jan 16, 2026 | SESE |
| K250679 | FFX Facet Fixation System | Sc Medica | Dec 4, 2025 | SESE |
| K253190 | CORUS-LX Implant | Providence Medical Technology, Inc. | Nov 20, 2025 | SESE |
| K252153 | FFX Facet Fixation System | Sc Medica | Oct 16, 2025 | SESE |
| K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant | Providence Medical Technology, Inc. | Jul 10, 2025 | SESE |
| K250920 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | May 22, 2025 | SESE |
| K242527 | The Karma® Fixation System | Spinal Elements, Inc. | May 21, 2025 | SESE |
| K243865 | AERO MIS Facet Fusion System | Aurora Spine | Mar 24, 2025 | SESE |
| K243265 | Ion 3D | SurGenTec, LLC | Dec 4, 2024 | SESE |
| K242650 | zLOCK Lumbar Facet Fixation System | Zygofix , Ltd. | Sep 20, 2024 | SESE |
| K241035 | PMT Posterior Cervical Stabilization System (PCSS) | Providence Medical Technology, Inc. | Jun 25, 2024 | SESE |
| K241416 | Ion 3D | SurGenTec, LLC | Jun 17, 2024 | SESE |
| K232468 | SC Medica FFX | Sc Medica | May 9, 2024 | SESE |
| K240085 | zLOCK Lumbar Facet Fixation System | Zygofix , Ltd. | Apr 18, 2024 | SESE |
| K240086 | Ion 3D | SurGenTec, LLC | Feb 8, 2024 | SESE |
| K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX) | Providence Medical Technology, Inc. | Dec 19, 2023 | SESE |
| K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System | K&J Consulting Corporation | Dec 13, 2023 | SESE |
| K230297 | PMT Expandable Cage (PMT EXP) | Providence Medical Technology, Inc. | Aug 11, 2023 | SESE |
Top Applicants
- Providence Medical Technology, Inc. — 9 clearances
- SurGenTec, LLC — 5 clearances
- Nuvasive, Inc. — 4 clearances
- Triage Medical, Inc. — 4 clearances
- Globus Medical, Inc. — 3 clearances