510(k) K992656 ยท JDC Prosthesis, Elbow, Constrained, Cemented
DEPUY TOTAL ELBOW SYSTEM
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 5, 1999 |
| Received | Aug 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992656
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2006 | Depuy Orthopaedics, Inc. Depuy brand Acclaim Elbow linked ulnar bearing, sterile; catalog # 1722-60-000. Terminated |
JDB | None listed |
| Feb 16, 2006 | Depuy Orthopaedics, Inc. Depuy brand Acclaim Elbow linked ulnar bearing assembly (ulnar bearing and locking screw), sterile; catalog # 1722-63-000. Terminated |
JDB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.