510(k) K130728 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA
| Applicant | Smith & Nephew, Inc., Cordova TN, US |
| Decision | Substantially Equivalent, Oct 10, 2013 |
| Received | Mar 18, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130728
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2017 | Smith & Nephew, Inc. smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 75102260, NON STERILE, QTY: (1), Rx only
The subject cardan is used in conjunction with a curved stem im Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.