ATEC ALIF and LLIF Spacer System

ATEC ALIF and LLIF Spacer System is an FDA 510(k)-cleared medical device (K182746) 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 26, 2018. Regulation: 8.