510(k) K070946 ยท HRS Plate, Fixation, Bone
SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, Jun 6, 2007 |
| Received | Apr 4, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070946
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2016 | Synthes (USA) Products LLC LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones. Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.