510(k) K081124 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
MDF REVISION HIP SYSTEM
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jul 31, 2008 |
| Received | Apr 21, 2008 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K081124
| 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 |
| Sep 20, 2012 | Smith & Nephew Inc 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA.
USE WITH SMITH & NEPHEW STEMS AND 12/14 F Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.