510(k) K252454 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Kinos Total Ankle System
| Applicant | Restor3D, Durham NC, US |
| Decision | Substantially Equivalent, Sep 3, 2025 |
| Received | Aug 4, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252454
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.