510(k) K111634 ยท NKB Thoracolumbosacral Pedicle Screw System
XENON(TM) PEDICLE SCREW SYSTEM
| Applicant | Alphatec Spine, Inc., Carlsnad CA, US |
| Decision | Substantially Equivalent, Jan 25, 2012 |
| Received | Jun 13, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111634
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.