K252153 is an FDA 510(k) clearance for the FFX Facet Fixation System. This device is classified as a System, Facet Screw Spinal Device.
Submitted by Sc Medica (Strasbourg, FR). The FDA issued a Cleared decision on October 16, 2025, 99 days after receiving the submission on July 9, 2025.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K252153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2025 |
| Decision Date | October 16, 2025 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MRW - System, Facet Screw Spinal Device |
| Device Class | - |