Blustone Synergy Diamond SA Cervical System

Blustone Synergy Diamond SA Cervical System is an FDA 510(k)-cleared medical device (K210382) manufactured by Blustone Synergy, 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 July 22, 2021. Regulation: 8.