510(k) K042365 ยท JEY Plate, Bone
SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Nov 18, 2004 |
| Received | Aug 31, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042365
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2020 | Synthes, Inc. MatrixNEURO 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 repair, Terminated |
JEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.