VertiForm Posterior Fixation System

VertiForm Posterior Fixation System is an FDA 510(k)-cleared medical device (K161499) manufactured by Next Orthosurgical. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 28, 2016. Regulation: 8.