CapLOX II®/TowerLOX® MIS Pedicle Screw System

CapLOX II®/TowerLOX® MIS Pedicle Screw System is an FDA 510(k)-cleared medical device (K193270) manufactured by Captiva Spine, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 30, 2020. Regulation: 8.