Vy Spine™ VySpan™ PCT System

Vy Spine™ VySpan™ PCT System is an FDA 510(k)-cleared medical device (K213394) 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 December 9, 2021. Regulation: 8.