ATEC Posterior Navigated Disc Prep Instruments

ATEC Posterior Navigated Disc Prep Instruments is an FDA 510(k)-cleared medical device (K232345) manufactured by Alphatec Spine, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 1, 2023. Regulation: 8.