510(k) K100757 ยท NKB Thoracolumbosacral Pedicle Screw System
TILOCK PEDICLE SCREW SYSTEM
| Applicant | Genesys Spine, Austin TX, US |
| Decision | Substantially Equivalent, Jul 1, 2010 |
| Received | Mar 17, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100757
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2014 | Genesys Orthopedics Systems, LLC Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System.
The TiLock Pedicle Screw System is intended to provide immobilization and st Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.