510(k) K040487 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
TRABECULAR METAL KNEE SYSTEM AUGMENTS
| Applicant | Implex Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Dec 21, 2004 |
| Received | Feb 25, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040487
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2015 | Zimmer Trabecular Metal Technology, Inc. NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only.
Product Usage:
Intended for use where severe degeneration, trauma, or other pathology of the knee j Terminated |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.