VersaLink™ Fixation System

VersaLink™ Fixation System is an FDA 510(k)-cleared medical device (K182598) manufactured by Premia Spine, Ltd.. 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 12, 2018. Regulation: 8.