510(k) K120070 ยท HRS Plate, Fixation, Bone
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
| Applicant | Synthes USA, West Chester PA, US |
| Decision | Substantially Equivalent, Mar 21, 2012 |
| Received | Jan 9, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120070
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2015 | Synthes (USA) Products LLC Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile
The Synthes 2.7 mm/3.5 mm Varia Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.