510(k) K071380 ยท NKB Thoracolumbosacral Pedicle Screw System
MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
| Applicant | Alphatec Spine, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Aug 20, 2007 |
| Received | May 17, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071380
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2012 | Alphatec Spine, Inc. Solanas Posterior Stabilization System Part Number: 63920.
Solanas Posterior Stabilization System facilitates the surgical correction of spinal deformities by providing temporary internal fixation an Terminated |
KWP | None listed |
| Dec 14, 2009 | Alphatec Spine, Inc. Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12 Terminated |
KWP | None listed |
| Dec 14, 2009 | Alphatec Spine, Inc. Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14 Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.