HARRIER-SA™ Lumbar Interbody System

HARRIER-SA™ Lumbar Interbody System is an FDA 510(k)-cleared medical device (K180519) manufactured by Choicespine, LP. 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 15, 2018. Regulation: 8.