ATEC Lateral Interbody System

ATEC Lateral Interbody System is an FDA 510(k)-cleared medical device (K202587) 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 November 5, 2020. Regulation: 8.