510(k) K061243 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal
SMITH & NEPHEW MODULAR FEMORAL HEAD
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jul 17, 2006 |
| Received | May 3, 2006 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K061243
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2015 | Smith & Nephew, Inc. BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers:
74121238, MODULAR HEAD 38 MM -8MM
74121242, MODULAR HEAD 42 MM -8MM
74121246, MODULAR HEAD 46 MM -8MM
74121250, MODULAR HEAD 50 MM -8MM
74121 Terminated |
KWL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.