VariAx Distal Radius Plating System, VariAx 2 System

VariAx Distal Radius Plating System, VariAx 2 System is an FDA 510(k)-cleared medical device (K162841) manufactured by Stryker GmbH. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 20, 2017. Regulation: 8.