Genesys Spine 3DP AIS-C II Cervical Interbody System

Genesys Spine 3DP AIS-C II Cervical Interbody System is an FDA 510(k)-cleared medical device (K233594) 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 December 12, 2023. Regulation: 8.