510(k) K153657 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Vanguard XP Knee System
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, May 10, 2016 |
| Received | Dec 21, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153657
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2019 | Zimmer Biomet, Inc. XP-XP Tibial Tray - Interlok 59 mm
Item # 195750 Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.