510(k) K022958 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
TOTAL HIP FEMORAL HEADS AND LINERS
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Oct 2, 2002 |
| Received | Sep 6, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022958
| 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.