510(k) K083388 ยท JEY Plate, Bone
SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, Mar 12, 2009 |
| Received | Nov 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083388
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2015 | Synthes (USA) Products LLC Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intende Terminated |
JEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.