VyBrate™ VBR System

VyBrate™ VBR System is an FDA 510(k)-cleared medical device (K253158) manufactured by Vy Spine, 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 January 6, 2026. Regulation: 8.