510(k) K973357 ยท JDC Prosthesis, Elbow, Constrained, Cemented
COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 2, 1998 |
| Received | Sep 8, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973357
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2012 | Zimmer, Inc. COONMAD/MORREY TOTAL ELBOW
ELBOW COMPONENT REPLACEMENT SET
BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW
ELBOW COMP REPLACEMENT-REG SET
STERILE PROD CLASS: 4100
OPERATION:9000
QTY/PKG:1
Product Usage Terminated |
JDC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.