510(k) K083651 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
REVELATION STEM, MODEL 427-21/42-080/180
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, Mar 13, 2009 |
| Received | Dec 9, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083651
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.