510(k) K082797 ยท NKB Thoracolumbosacral Pedicle Screw System
BLACKSTONE PEDICLE SCREW SYSTEM
| Applicant | Blackstone Medical, Inc., Wayne NJ, US |
| Decision | Substantially Equivalent, Oct 17, 2008 |
| Received | Sep 23, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082797
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.