510(k) K970031 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
FOUNDATION KNEE SYSTEM TIBIAL COMPONENT
| Applicant | Encore Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Apr 2, 1997 |
| Received | Jan 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970031
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2011 | Encore Medical, Lp Foundation Tibial Broach P/N 801-01-013
Foundation Tibial Broach to be used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for accepta Terminated |
JWH | None listed |
| Sep 29, 2008 | Encore Medical, Lp FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of the FOUNDATION KNEE S Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.