IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System

IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System is an FDA 510(k)-cleared medical device (K251575) manufactured by Alphatec Spine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 2, 2025. Regulation: 8.