510(k) K253517 ยท HSB Rod, Fixation, Intramedullary And Accessories
Reselute Tibial Nail
| Applicant | Reselute, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Mar 10, 2026 |
| Received | Nov 12, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253517
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.