Kodiak Spinal Fixation System

Kodiak Spinal Fixation System is an FDA 510(k)-cleared medical device (K181677) manufactured by Alphatec Spine, 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 August 8, 2018. Regulation: 8.