510(k) K181603 ยท NKG Posterior Cervical Screw System
EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System
| Applicant | K2m, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, Oct 5, 2018 |
| Received | Jun 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181603
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.