LumiVy™ Lumbar IBF System

LumiVy™ Lumbar IBF System is an FDA 510(k)-cleared medical device (K223412) 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 5, 2023. Regulation: 8.