510(k) K192778 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Kinos Axiom Total Ankle System
| Applicant | Kinos Medical, Wayne PA, US |
| Decision | Substantially Equivalent, Jun 30, 2020 |
| Received | Sep 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192778
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.