510(k) K962196 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
NEXGEN KNEE PROSTHESIS & LEGACY KNEE PROSTHESIS W/CO-NIDIUM SURFACE HARDENING PROCESS
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 23, 1996 |
| Received | Jun 6, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962196
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2016 | Zimmer Biomet, Inc. NexGen Knee CR Porous FEM
NexGen Knee CR Precoat FEM
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
various sizes
"" This device is indicated for patients wit Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.