Bi-Ostetic Bioactive Glass Foam

Bi-Ostetic Bioactive Glass Foam is an FDA 510(k)-cleared medical device (K170917) manufactured by Berkeley Advanced Biomaterials. 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 29, 2017. Regulation: 8.