SurgTech GENOLL Total Knee System

SurgTech GENOLL Total Knee System is an FDA 510(k)-cleared medical device (K191192) manufactured by Surgtech, 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 July 31, 2019. Regulation: 8.