510(k) K030259 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
AMATOMICAL SHOULDER WITH REMOVABLE HEAD
| Applicant | Centerplus Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Apr 24, 2003 |
| Received | Jan 24, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030259
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2012 | Zimmer, Inc. Anatomical Shoulder" Humeral stem Terminated |
KWS | None listed |
| Nov 6, 2012 | Zimmer, Inc. Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and
Anatomical Shoulder Fracture Humeral stem Terminated |
KWS | None listed |
| Nov 6, 2012 | Zimmer, Inc. Anatomical Shoulder" Ball taper for humeral stem Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.