HD LifeSciences Cervical IBFD System

HD LifeSciences Cervical IBFD System is an FDA 510(k)-cleared medical device (K180364) manufactured by Hd Lifesciences, 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 June 26, 2018. Regulation: 8.