510(k) K001941 ยท HRS Plate, Fixation, Bone
SYNTHES MODULAR FOOT SYSTEM
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Sep 22, 2000 |
| Received | Jun 26, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001941
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 27, 2013 | Synthes (USA) Products LLC Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm
Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand. Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.