Range/Denali/Mesa Spinal System

Range/Denali/Mesa Spinal System is an FDA 510(k)-cleared medical device (K171832) 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 September 13, 2017. Regulation: 8.