510(k) K012114 ยท HRS Plate, Fixation, Bone
SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Sep 28, 2001 |
| Received | Jul 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012114
| 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 |
| Jan 11, 2007 | Synthes LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465 Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.