VyLink™ Spinal Screw System

VyLink™ Spinal Screw System is an FDA 510(k)-cleared medical device (K231744) 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 October 12, 2023. Regulation: 8.