EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System

EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System is an FDA 510(k)-cleared medical device (K181603) manufactured by K2m, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 4, 2018. Regulation: 8.