Blustone Synergy Interbody Fusion System

Blustone Synergy Interbody Fusion System is an FDA 510(k)-cleared medical device (K203520) 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 April 6, 2021. Regulation: 8.