CORE PEDICLE SCREW SYSTEM

CORE PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K131522) manufactured by Core-Nexus. 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 8, 2013. Regulation: 8.