DYNA-LINK ELITE Stand-Alone Anterior Lumbar System

DYNA-LINK ELITE Stand-Alone Anterior Lumbar System is an FDA 510(k)-cleared medical device (K180215) manufactured by Life Spine, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 12, 2018. Regulation: 8.