EDGE ORTHOPAEDICS BITE COMPRESSION SCREW

EDGE ORTHOPAEDICS BITE COMPRESSION SCREW is an FDA 510(k)-cleared medical device (K132893) manufactured by Icon Orthopaedic Concepts Dba Edge Orthopaedics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 19, 2013. Regulation: 8.