Elite L Expandable Lumbar Fusion System

Elite L Expandable Lumbar Fusion System is an FDA 510(k)-cleared medical device (K150954) manufactured by Innova Spinal Technologies, 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 May 6, 2015. Regulation: 8.