510(k) K191393 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
INFINITY Total Ankle System, INBONE Total Ankle System
| Applicant | Wrightmedicaltechnologyinc, Memphis TN, US |
| Decision | Substantially Equivalent, Aug 22, 2019 |
| Received | May 24, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191393
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.