510(k) K250037 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Incompass Total Ankle System
| Applicant | Wright Medical Technology, Inc. (Stryker), Memphis TN, US |
| Decision | Substantially Equivalent, Jun 20, 2025 |
| Received | Jan 8, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250037
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.