510(k) K961890 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
FOUNDATION 9MM FORGED CEMENTED STEM
| Applicant | Encore Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Jun 14, 1996 |
| Received | May 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961890
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Encore Medical, Lp FOUNDATION HIP SYSTEM Series 460 Hip Stem STERILE R CEMENTED Sz 16.5mm
DJO Surgical 9800 Metric Blvd., Austin, TX 78758
The Foundation Non-Porous Stem is intended for treatment of patients who are c Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.