510(k) K201701 ยท MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
R3 HA Coated Acetabular Shells
| Applicant | Smith & Nephew, Inc., Cordova TN, US |
| Decision | Substantially Equivalent, Oct 6, 2020 |
| Received | Jun 22, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201701
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.