510(k) K904880 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
BUECHEL-PAPPAS HUMERAL STEM COMPONENT
| Applicant | Endotec, Inc., South Orange NJ, US |
| Decision | Substantially Equivalent, Jan 28, 1991 |
| Received | Oct 30, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904880
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2010 | Endotec, Inc. Endotec Prosthesis Shoulder, Titanium Alloy, Sterilized
Modular Femoral Stem BP Shoulder Component:
12mm Modular Femoral Stem, Catalog: 02-21-0103, Lot 02-21-0103ANN374. Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.