510(k) K923277 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
FOUNDATION KNEE SYSTEM
| Applicant | Encore Orthopedics, Inc., Red Rock TX, US |
| Decision | Substantially Equivalent, Feb 9, 1993 |
| Received | Jul 6, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923277
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Dec 29, 2005 | Encore Medical, Lp Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement. Terminated |
JWH | None listed |
| Jul 20, 2004 | Encore Medical, LP Foundation Knee System, Tibia-Nonporous, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758 Terminated |
JWH | None listed |
| Jul 30, 2003 | Encore Medical, LP Foundation Knee System, non-porous Femur Size 8, Right Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.