510(k) K915818 ยท HRS Plate, Fixation, Bone
SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Jan 17, 1992 |
| Received | Dec 30, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915818
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2015 | Synthes (USA) Products LLC Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant. Terminated |
HRS | None listed |
| Mar 11, 2014 | Synthes, Inc. Synthes Small Notch Titanium Reconstructive Plate
Product Usage:
The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercial Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.