510(k) K030766 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
OXINIUM FEMORAL HEADS
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jul 25, 2003 |
| Received | Mar 11, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030766
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2009 | Smith & Nephew Inc Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603, Sterile, Smith & Nephew, Memphis TN 38116 Terminated |
JDI | None listed |
| Sep 24, 2009 | Smith & Nephew Inc Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116
Designed for use with femoral stems and acetabular
components distributed by Smith & Nephew. Terminated |
LZY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.