HammerTechTM Fixation System

HammerTechTM Fixation System is an FDA 510(k)-cleared medical device (K182684) manufactured by Fusion Orthopedics, 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 November 22, 2018. Regulation: 8.