TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System

TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System is an FDA 510(k)-cleared medical device (K231504) manufactured by Vilex, 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 10, 2023. Regulation: 8.