510(k) K010499 ยท JEY Plate, Bone
SYNTHES (USA) MIDFACE DISTRACTOR
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, May 3, 2001 |
| Received | Feb 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010499
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2013 | Synthes USA HQ, Inc. Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones. Terminated |
JEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.