Reform® Midline Cortical Screw System

Reform® Midline Cortical Screw System is an FDA 510(k)-cleared medical device (K173130) manufactured by Precision Spine, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 18, 2017. Regulation: 8.