510(k) K081195 ยท NKB Thoracolumbosacral Pedicle Screw System
REVERE UNIPLANAR SCREWS
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, May 28, 2008 |
| Received | Apr 28, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081195
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.