510(k) K974017 ยท HRS Plate, Fixation, Bone
TIMESH SYSTEM
| Applicant | Sofamor Danek USA,Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jan 16, 1998 |
| Received | Oct 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974017
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2006 | Medtronic Neurosurgery Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft, Catalog Number 8001215
The 8001215 Screwdriver is a stainless steel part designed for use with cruciate-style screws in the firm' Terminated |
GXL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.