ChoiceSpine Tiger Shark Cervical Spacer System

ChoiceSpine Tiger Shark Cervical Spacer System is an FDA 510(k)-cleared medical device (K201643) 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 December 21, 2020. Regulation: 8.