510(k) K141407 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 27, 2014 |
| Received | May 28, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141407
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2016 | Biomet, Inc. Vanguard XP Knee System Porous Femoral Component
various sizes and orientation a total knee replacement system.
prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous,
coated, Terminated |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.