510(k) K211548 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
POLARSTEM Calcar Reamer Guide
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jul 19, 2021 |
| Received | May 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211548
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.