Altus Spine HA Pedicle Screw System

Altus Spine HA Pedicle Screw System is an FDA 510(k)-cleared medical device (K200922) 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 January 25, 2021. Regulation: 8.