Standalone ALIF Interbody Fusion System

Standalone ALIF Interbody Fusion System is an FDA 510(k)-cleared medical device (K221936) manufactured by Eminent 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 October 16, 2022. Regulation: 8.