Bicortical Fixation Screw & Washer Nut System

Bicortical Fixation Screw & Washer Nut System is an FDA 510(k)-cleared medical device (K153638) manufactured by First Ray, 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 April 18, 2016. Regulation: 8.