AxTiHA Stand-Alone ALIF System

AxTiHA Stand-Alone ALIF System is an FDA 510(k)-cleared medical device (K212967) manufactured by Innovasis, 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 October 14, 2021. Regulation: 8.