Black Diamond Pedicle Screw System

Black Diamond Pedicle Screw System is an FDA 510(k)-cleared medical device (K192121) manufactured by Osseus Fusion Systems. 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 28, 2019. Regulation: 8.