RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM

RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K133944) 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 March 20, 2014. Regulation: 8.