Genesys Spine 3DP Cervical Interbody System

Genesys Spine 3DP Cervical Interbody System is an FDA 510(k)-cleared medical device (K191489) 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 January 7, 2020. Regulation: 8.