Altus Spine Monaco Pedicle Screw System

Altus Spine Monaco Pedicle Screw System is an FDA 510(k)-cleared medical device (K230766) manufactured by Altus Spine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 18, 2023. Regulation: 8.