510(k) K251135 ยท HRS Plate, Fixation, Bone
Treace Medical Concepts (TMC) Implant Fixation System
| Applicant | Treace Medical Concepts, Ponte Vedra FL, US |
| Decision | Substantially Equivalent, Aug 21, 2025 |
| Received | Apr 14, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251135
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.