510(k) K024161 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS
| Applicant | Implex Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Jan 15, 2003 |
| Received | Dec 17, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K024161
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2019 | Zimmer Trabecular Metal Technology, Inc. NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws
Item Number: 00544800426
Product Usage:
The Trabecular Metal Tibial Cone Augments are inten Terminated |
JWH | None listed |
| Feb 1, 2019 | Zimmer Trabecular Metal Technology, Inc. NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws
Item Number: 00544800436
Product Usage:
The Trabecular Metal Tibial Cone Augments are inten Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.