RANGE/DENALI/MESA Spinal System

RANGE/DENALI/MESA Spinal System is an FDA 510(k)-cleared medical device (K153031) manufactured by K2m, Incorporated. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 16, 2015. Regulation: 8.