510(k) K013042 ยท JDC Prosthesis, Elbow, Constrained, Cemented
DISCOVERY ELBOW
| Applicant | Biomet Orthopedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 10, 2001 |
| Received | Sep 10, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013042
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2014 | Biomet, Inc. DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY.
Elbow joint replacement prostheses are intended for primary and revision joint arthropla Terminated |
JDC | None listed |
| Oct 3, 2008 | Biomet, Inc. Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114813. The produ Terminated |
JDC | None listed |
| Oct 3, 2008 | Biomet, Inc. Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114817. The prod Terminated |
JDC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.