510(k) K193067 · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total Ankle Revision System
| Applicant | Wrightmedicaltechnologyinc, Memphis TN, US |
| Decision | Substantially Equivalent, Jun 8, 2020 |
| Received | Nov 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193067
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.