510(k) K083694 ยท HRS Plate, Fixation, Bone
SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, Mar 6, 2009 |
| Received | Dec 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083694
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2013 | Synthes (USA) Products LLC Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm
Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular frac Terminated |
HRS | None listed |
| Aug 26, 2013 | Synthes USA HQ, Inc. Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right
Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other s Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.