510(k) K083782 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
REGENEREX PATELLA COMPONENTS
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Apr 3, 2009 |
| Received | Dec 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083782
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2020 | Biomet, Inc. Knee Products:
141356 Regenerex Series-A Patella 3 Peg, 31 MM
141358 Regenerex Series-A Patella 3 Peg, 37 MM
Product Usage: Knee prosthesis Terminated |
MBH | None listed |
| Apr 25, 2017 | Zimmer Biomet, Inc. Regenerex Patella
RGX 3 PEG SER A PATELLA 28MM
RGX 3 PEG SER A PATELLA 31MM
RGX 3 PEG SER A PATELLA 34MM
RGX 3 PEG SER A PATELLA 37MM
Product Usage:
The Regenerex Series A Patella can be used for any Terminated |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.