MAGEC Spinal Bracing and Distraction System

MAGEC Spinal Bracing and Distraction System is an FDA 510(k)-cleared medical device (K233593) manufactured by Nuvasive Specialized Orthopedics, Incorporated. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 5, 2024. Regulation: 8.