ATEC Cervical Spacer System

ATEC Cervical Spacer System is an FDA 510(k)-cleared medical device (K181435) 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 20, 2018. Regulation: 8.