Acapella Cervical Spacer System

Acapella Cervical Spacer System is an FDA 510(k)-cleared medical device (K171489) 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 October 22, 2017. Regulation: 8.