510(k) K260361 ยท HWC Screw, Fixation, Bone
Treace Medical Concepts (TMC) Screw Fixation System
| Applicant | Treace Medical Concepts, Inc., Ponte Vedra FL, US |
| Decision | Substantially Equivalent, Mar 6, 2026 |
| Received | Feb 4, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260361
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.