
Berkeley Advanced Biomaterials, Inc.
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BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM is an FDA 510(k)-cleared medical device (K053213) manufactured by Berkeley Advanced Biomaterials, Inc.. 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 5, 2006. Regulation: 8.