510(k) K143739 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
| Applicant | Smith & Nephew, Inc., Cordova TN, US |
| Decision | Substantially Equivalent, Apr 20, 2015 |
| Received | Dec 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143739
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2020 | Smith & Nephew Orthopaedics AG POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.