Blustone Synergy Silica System

Blustone Synergy Silica System is an FDA 510(k)-cleared medical device (K172330) manufactured by Blustone Synergy. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 20, 2017. Regulation: 8.