LumiVy Lumbar IBF System

LumiVy Lumbar IBF System is an FDA 510(k)-cleared medical device (K212930) 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 February 15, 2022. Regulation: 8.