Harrier-SA Lumbar Interbody System

Harrier-SA Lumbar Interbody System is an FDA 510(k)-cleared medical device (K191367) manufactured by Choice 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 July 4, 2019. Regulation: 8.