ChoiceSpine Blackhawk Ti Cervical Spacer System

ChoiceSpine Blackhawk Ti Cervical Spacer System is an FDA 510(k)-cleared medical device (K203311) 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 May 9, 2021. Regulation: 8.