510(k) K113364 ยท HRS Plate, Fixation, Bone
2.7MM LCP ULNA OSTEOTOMY SYSTEM
| Applicant | Synthes (USA) Products, LLC, West Chester PA, US |
| Decision | Substantially Equivalent, Feb 29, 2012 |
| Received | Nov 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113364
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2014 | Synthes, Inc. Drill Template and the Saw Guide for the Ulna Osteotomy System.
Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, includi Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.