510(k) K955731 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
OSTEONICS SHOULDER HUMERAL COMPONENTS
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent for Some Indications, Mar 5, 1996 |
| Received | Dec 18, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955731
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2009 | Stryker Howmedica Osteonics Corp. Solar Shoulder Humeral Stem
These devices are modular components of a total shoulder system. These humeral stems are intended for use with humeral heads and glenoid components in primary or revision Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.