K250920 is an FDA 510(k) clearance for the Arthrex Spine Compression FT Screw. This device is classified as a System, Facet Screw Spinal Device.
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on May 22, 2025, 56 days after receiving the submission on March 27, 2025.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K250920 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2025 |
| Decision Date | May 22, 2025 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MRW — System, Facet Screw Spinal Device |
| Device Class | — |