510(k) K080625 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
SMITH & NEPHEW MIS HIP STEM WITH STIKTITE
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, May 8, 2008 |
| Received | Mar 5, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080625
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2016 | Smith & Nephew, Inc. Modular Necks:
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 rehabilitat Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.