510(k) K250641 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
APEX 3D Total Ankle Replacement System
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, May 1, 2025 |
| Received | Mar 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250641
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.