510(k) K183343 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Vantage Total Ankle Flat Cut Talar Components
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Apr 1, 2019 |
| Received | Dec 3, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183343
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.