510(k) K950542 ยท JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
METAL BACKED ACETABULAR COMPONENT
| Applicant | Encore Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, May 25, 1995 |
| Received | Feb 7, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950542
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2006 | Encore Medical, Lp Porous titanium flared rim acetabular shell with three clustered holes in even sizes from 48 to 66mm, a hip prosthesis component. The lot number on the product labeling is the unique identifier of th Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.