Genesys Spine AIS-C Cervical Stand-Alone System

Genesys Spine AIS-C Cervical Stand-Alone System is an FDA 510(k)-cleared medical device (K181295) 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 August 28, 2018. Regulation: 8.