510(k) K042093 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 1, 2004 |
| Received | Aug 3, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042093
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2020 | Biomet, Inc. Knee Products:
US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8
US154722 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Terminated |
HRY | None listed |
| Jun 15, 2015 | Biomet, Inc. Vanguard M Unicondylar Tibial Trial
For use during knee joint replacement. Terminated |
HRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.