TxTiHA IBF System, AxTiHA Stand-Alone ALIF System

TxTiHA IBF System, AxTiHA Stand-Alone ALIF System is an FDA 510(k)-cleared medical device (K201614) 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 July 14, 2020. Regulation: 8.