SureMAX Family of Cervical Spacers

SureMAX Family of Cervical Spacers is an FDA 510(k)-cleared medical device (K193359) manufactured by Additive Implants, 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 January 2, 2020. Regulation: 8.