510(k) K131119 ยท NKB Thoracolumbosacral Pedicle Screw System
SOLANAS POSTERIOR STABILIZATION SYSTEM
| Applicant | Alphatec Spine, Inc., Carlsnad CA, US |
| Decision | Substantially Equivalent, May 21, 2013 |
| Received | Apr 22, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131119
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2014 | Alphatec Spine, Inc. Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thora Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.