PressON Pro Spinal Fixation System

PressON Pro Spinal Fixation System is an FDA 510(k)-cleared medical device (K160820) manufactured by Nexus 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 June 27, 2016. Regulation: 8.