ChoiceSpine Stealth Cervical Spacer System

ChoiceSpine Stealth Cervical Spacer System is an FDA 510(k)-cleared medical device (K183397) 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 March 5, 2019. Regulation: 8.