Synapse Occipital-Cervical-Thoracic (OCT) System

Synapse Occipital-Cervical-Thoracic (OCT) System is an FDA 510(k)-cleared medical device (K142838) manufactured by Synthes USA Products, LLC. 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 19, 2015. Regulation: 8.