510(k) K013385 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jan 9, 2002 |
| Received | Oct 12, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013385
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2004 | Zimmer Inc. Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 2, sterile, for cemented use only; Cat. No. 5880-02-02. Terminated |
KRO | None listed |
| Sep 14, 2004 | Zimmer Inc. Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 3, sterile, for cemented use only; Cat. No. 5880-03-02. Terminated |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.