OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM

OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K131810) manufactured by Osseus Fusion Systems, 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 August 7, 2013. Regulation: 8.