SYNFIX Evolution Secured Spacer System

SYNFIX Evolution Secured Spacer System is an FDA 510(k)-cleared medical device (K150673) 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 August 20, 2015. Regulation: 8.