510(k) K080361 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
REGENEREX TIBIAL COMPONENTS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Apr 21, 2008 |
| Received | Feb 11, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080361
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2020 | Biomet, Inc. Biomet Regenerex Primary Taper Cap
Item Number 141269 Terminated |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.