Caspian OCT/MESA Mini/DENALI Mini Spinal System

Caspian OCT/MESA Mini/DENALI Mini Spinal System is an FDA 510(k)-cleared medical device (K153370) 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 February 15, 2016. Regulation: 8.