Altus Spine Pedicle Screw System

Altus Spine Pedicle Screw System is an FDA 510(k)-cleared medical device (K200322) manufactured by Altus Partners, 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 1, 2020. Regulation: 8.