510(k) K113789 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
MODULAR PROXIMALLY FLUTED HIP STEM
| Applicant | Smith & Nephew, Inc., Cordova TN, US |
| Decision | Substantially Equivalent, Apr 19, 2012 |
| Received | Dec 22, 2011 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K113789
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2016 | Smith & Nephew, Inc. Modular SMF(TM)
The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilita Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.