510(k) K240591 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
restor3d Kinos Axiom Total Ankle System
| Applicant | Restor3D, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Apr 29, 2024 |
| Received | Mar 1, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240591
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.