510(k) K051975 ยท JDC Prosthesis, Elbow, Constrained, Cemented
POROUS COATED DISCOVERY ELBOW
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 6, 2005 |
| Received | Jul 21, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051975
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 21, 2012 | Biomet, Inc. Discovery Elbow System Humeral Condyle Set- Hexalobular, REF 114700, Lot 797550 Alloy, Sterile, Biomet Orthopedics Warsaw IN 46581.
Intended for primary and revision joint arthroplasty for use in cem Terminated |
JDC | None listed |
| Jun 24, 2011 | Biomet, Inc. Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW SYSTEM, HUMERAL CONDYLE SET - HEXALOBULAR, CO-CR-MO / YI-GAL-4V ALLOY, IF USED FOR REVISION SURGERY, INSTRUMENTS 414926 & 414923 MAY BE REQUIR Terminated |
JDC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.