VariAx 2 Compression Plating System

VariAx 2 Compression Plating System is an FDA 510(k)-cleared medical device (K170727) 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 June 21, 2017. Regulation: 8.