510(k) K162641 · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Smith & Nephew, Inc. R3 Constrained Liner
| Applicant | Smith & Nephew, Inc., Cordova TN, US |
| Decision | Substantially Equivalent, Jun 19, 2017 |
| Received | Sep 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162641
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.