ALTUS SPINE PEDICLE SCREW SYSTEM

ALTUS SPINE PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K132280) manufactured by Altus Partners. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 30, 2013. Regulation: 8.