PANAMA™ Anterior Cervical Plate (ACP) System

PANAMA™ Anterior Cervical Plate (ACP) System is an FDA 510(k)-cleared medical device (K210182) manufactured by Flospine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 6, 2021. Regulation: 8.