510(k) K040588 ยท HRS Plate, Fixation, Bone
SYNTHES (USA) 2.4 MM LCP WRIST PLATE
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, May 7, 2004 |
| Received | Mar 5, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040588
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.