510(k) K992000 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
SYNTHES CRANIAL FLAP TUBE CLAMP
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Jul 20, 1999 |
| Received | Jun 15, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992000
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2015 | Synthes (USA) Products LLC Synthes Cranial Flap Tube Clamp and Crimping Device
Product Usage:
The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotom Terminated |
GXN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.