510(k) K142403 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System
| Applicant | Zimmer GmbH, Winterthur, CH |
| Decision | Substantially Equivalent, Nov 24, 2014 |
| Received | Aug 27, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142403
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 17, 2016 | Zimmer Gmbh Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0.
The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retro Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.