510(k) K050608 ยท JEY Plate, Bone
SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, May 18, 2005 |
| Received | Mar 10, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050608
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2020 | Synthes Produktions GmbH MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repai Terminated |
JEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.