510(k) K191835 ยท NKB Thoracolumbosacral Pedicle Screw System
CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, Aug 6, 2019 |
| Received | Jul 9, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191835
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.