510(k) K152494 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 25, 2015 |
| Received | Sep 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152494
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2018 | Zimmer Biomet, Inc. NexGen Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw
Item Number: 00599003523
NexGen Distal Femoral Augment Block is used when femoral components can neither be do Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.