510(k) K092331 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110;
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, Mar 3, 2010 |
| Received | Aug 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092331
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2017 | Encore Medical, Lp LIMA Modular Revision Hip Stem Model 428-01-050_110
Product Usage:
The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilized d Terminated |
KWA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.