G3(TM) Active Plate(R) Small Fragment System

G3(TM) Active Plate(R) Small Fragment System is an FDA 510(k)-cleared medical device (K160633) manufactured by Genesis Fracture Care, Inc.. 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 21, 2016. Regulation: 8.