510(k) K102694 ยท HRS Plate, Fixation, Bone
2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, Dec 9, 2010 |
| Received | Sep 20, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102694
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2016 | Synthes (USA) Products LLC Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices
Terminated |
HRS | None listed |
| Nov 2, 2015 | Synthes (USA) Products LLC 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly Terminated |
HWC | None listed |
| Mar 15, 2013 | Synthes USA HQ, Inc. Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431.
Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Corrective osteotomies Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.