510(k) K050222 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 16, 2005 |
| Received | Jan 31, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050222
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2024 | Biomet, Inc. Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a
polyurethane bag, and sealed Open, Classified |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.