510(k) K053189 ยท JDC Prosthesis, Elbow, Constrained, Cemented
COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Dec 9, 2005 |
| Received | Nov 15, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053189
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2009 | Zimmer Inc. Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, left, 3 inch length, sterile, Zimmer, Warsaw, IN; REF 32-8105-043-01.
The device is utilized for a tota Terminated |
JDC | None listed |
| Apr 2, 2009 | Zimmer Inc. Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, right, 3 inch length, sterile, Zimmer, Warsaw, IN; REF 32-8105-043-02.
The device is utilized for a tot Terminated |
JDC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.