510(k) K932425 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
FOUNDATION MODULAR TIBIAL BASEPLATE
| Applicant | Encore Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent for Some Indications, Jul 22, 1994 |
| Received | May 19, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932425
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2010 | Encore Medical, Lp Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left Terminated |
JWH | None listed |
| Jan 13, 2010 | Encore Medical, Lp Foundation Tibia Baseplate, Catalog number 324-01-108. The tibial is modular in design, such that plastic inserts of various thicknesses and intramedullary stem are attached to the metal baseplate in Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.