Genesys Spine AIS-C II Cervical Interbody Fusion System

Genesys Spine AIS-C II Cervical Interbody Fusion System is an FDA 510(k)-cleared medical device (K242483) manufactured by Genesys 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 February 6, 2025. Regulation: 8.