POLYGRAFT BGS; BONE GRAFT SUBSTITUTE

POLYGRAFT BGS; BONE GRAFT SUBSTITUTE is an FDA 510(k)-cleared medical device (K041382) manufactured by Osteobiologics, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 16, 2005. Regulation: 8.