MRW — System, Facet Screw Spinal Device Class U
FDA Device Classification
Classification Details
- Product Code
- MRW
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Unknown
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251714 | surgentec | Ion-C | January 16, 2026 |
| K250679 | sc medica | FFX Facet Fixation System | December 4, 2025 |
| K253190 | providence medical technology | CORUS-LX Implant | November 20, 2025 |
| K252153 | sc medica | FFX Facet Fixation System | October 16, 2025 |
| K251885 | providence medical technology | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant | July 10, 2025 |
| K250920 | arthrex | Arthrex Spine Compression FT Screw | May 22, 2025 |
| K242527 | spinal elements | The Karma® Fixation System | May 21, 2025 |
| K243865 | aurora spine | AERO MIS Facet Fusion System | March 24, 2025 |
| K243265 | surgentec | Ion 3D | December 4, 2024 |
| K242650 | zygofix | zLOCK Lumbar Facet Fixation System | September 20, 2024 |
| K241035 | providence medical technology | PMT Posterior Cervical Stabilization System (PCSS) | June 25, 2024 |
| K241416 | surgentec | Ion 3D | June 17, 2024 |
| K232468 | sc medica | SC Medica FFX | May 9, 2024 |
| K240085 | zygofix | zLOCK Lumbar Facet Fixation System | April 18, 2024 |
| K240086 | surgentec | Ion 3D | February 8, 2024 |
| K230840 | providence medical technology | PMT Facet Fixation System, Lumbar (PMT FFS-LX) | December 19, 2023 |
| K232877 | k and j consulting corporation | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinou | December 13, 2023 |
| K230297 | providence medical technology | PMT Expandable Cage (PMT EXP) | August 11, 2023 |
| K220951 | providence medical technology | PMT Facet Fixation System (PMT FFS) | December 9, 2022 |
| K222515 | dio medical corporation | FaSet Fixation System | October 5, 2022 |