510(k) K083779 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
MAK OSS KNEE FEMORAL 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 K083779
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2012 | Biomet, Inc. REF. CP113456, MAK OSS No Head Lock Pin, NO HEAD / WITH PLUG CO-CR-MO ALLOY/ARCOM UHMWPE
STERILE, R, Biomet Orthopedics Warsaw, IN 46581.
The MAK OSS No Head Metal Lock Pin is to be inserted into Terminated |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.