510(k) K012866 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0
| Applicant | Implex Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Sep 26, 2001 |
| Received | Aug 27, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012866
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2013 | Zimmer, Inc. NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm.
Used to prepare cylindrical holes in the native tibia. Terminated |
HTW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.