SANTIS PEDICLE SCREW SYSTEM

SANTIS PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K133063) manufactured by Lanterna Medical Technologies. 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 12, 2014. Regulation: 8.