Whistler Modular Pedicle Screw System

Whistler Modular Pedicle Screw System is an FDA 510(k)-cleared medical device (K182478) manufactured by Evolution Spine, 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 January 14, 2019. Regulation: 8.