SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM

SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM is an FDA 510(k)-cleared medical device (K141897) 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 September 24, 2014. Regulation: 8.