510(k) K250713 · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Dec 1, 2025 |
| Received | Mar 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250713
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.