MAGEC® Spinal Bracing and Distraction System

MAGEC® Spinal Bracing and Distraction System is an FDA 510(k)-cleared medical device (K160352) manufactured by Nuvasive Specialized Orthopedics, 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 October 20, 2016. Regulation: 8.