CapLOX II/TowerLOX Pedicle Screw System

CapLOX II/TowerLOX Pedicle Screw System is an FDA 510(k)-cleared medical device (K151116) manufactured by Captiva Spine. 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 25, 2015. Regulation: 8.