510(k) K071174 ยท NKB Thoracolumbosacral Pedicle Screw System
PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS
| Applicant | Abbott Spine, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Jul 25, 2007 |
| Received | Apr 27, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071174
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2010 | Zimmer Inc. Pathfinder End Screw Extender Sleeve, REF 1165-10, Rx, non-sterile, sold under label Abbott Spine, Inc. Austin TX (prior to 2008) and Zimmer Spine Austin TX (7/2009 to present) Terminated |
NKB | None listed |
| Aug 31, 2010 | Zimmer Inc. Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1160-2.
Usage: The screwdriver is intended to mate to the hexalobular Terminated |
MNI | None listed |
| Sep 5, 2008 | Abbott Spine PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, Inc., Austin, TX 78727. Terminated |
NKB | None listed |
| Sep 1, 2008 | Abbott Spine PathFinder Spinal Fixation System T-Handle Driver; Part 2151-7 (13" shaft); Non-sterile, Reusable Instrument; manufactured by Abbott Spine, Austin, TX 78727. Terminated |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.