510(k) K063049 ยท HRS Plate, Fixation, Bone
SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, Dec 18, 2006 |
| Received | Oct 4, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063049
| 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 |
| Oct 30, 2015 | Synthes (USA) Products LLC 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of Terminated |
HRS | None listed |
| Nov 22, 2013 | Synthes USA HQ, Inc. 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM
Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.