510(k) K112030 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
| Applicant | Synthes USA, LLC, West Chester PA, US |
| Decision | Substantially Equivalent, Jun 19, 2012 |
| Received | Jul 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112030
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2016 | Synthes (USA) Products LLC Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories
Product Usage:
Intended for primary and revision joint replacement of the radial head. Terminated |
KWI | None listed |
| May 3, 2013 | Synthes USA HQ, Inc. Synthes Radial Head Prosthesis: Trial Radial Head
Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome compon Terminated |
KWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.