RANGE/MESA/DENALI SPINAL SYSTEM

RANGE/MESA/DENALI SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K140765) 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 July 9, 2014. Regulation: 8.