510(k) K113366 ยท NKB Thoracolumbosacral Pedicle Screw System
LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM
| Applicant | Phygen, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jan 17, 2012 |
| Received | Nov 15, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113366
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2013 | Alphatec Spine, Inc. Leucadia Autolok" Polyaxial Pedicle Screw System.
Intended to help provide correction, immobilization and stabilization of spinal segments. Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.