510(k) K003801 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
ANATOMICAL PRESS-FIT HUMERAL STEM
| Applicant | Sulzer Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Feb 28, 2001 |
| Received | Dec 8, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003801
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2012 | Zimmer, Inc. Anatomical Shoulder" Humeral Head Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.