510(k) K211512 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
VISIONAIRE UK Patient Matched Cutting Guides
| Applicant | Smith & Nephew, Inc., Cordova TN, US |
| Decision | Substantially Equivalent, Sep 16, 2021 |
| Received | May 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211512
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.