510(k) K082625 ยท HRS Plate, Fixation, Bone
SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, Dec 17, 2008 |
| Received | Sep 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082625
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2010 | Synthes USA (HQ), Inc. 3.5mm LCP Periarticular Proximal Humerus Plates
Indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly for patients with osteopenic bone Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.