510(k) K021673 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jun 11, 2002 |
| Received | May 21, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021673
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2024 | Smith & Nephew Inc smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4 Open, Classified |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.