510(k) K101971 ยท NKB Thoracolumbosacral Pedicle Screw System
SYNTEC OS SPINAL FIXATION SYSTEM
| Applicant | Syntec Scientific Corp., Chang Hua, TW |
| Decision | Substantially Equivalent, Mar 25, 2011 |
| Received | Jul 13, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101971
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.