GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert

GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert is an FDA 510(k)-cleared medical device (K173875) manufactured by Stelkast, 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 January 18, 2018. Regulation: 8.