Genesys Spine Apache Interbody Fusion System

Genesys Spine Apache Interbody Fusion System is an FDA 510(k)-cleared medical device (K153123) 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 April 25, 2016. Regulation: 8.