510(k) K033707

POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX by Osteobiologics, Inc. — Product Code MQV

K033707 is an FDA 510(k) premarket notification submitted by Osteobiologics, Inc. for the device "POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX". The FDA issued a decision of Substantially Equivalent on August 16, 2004. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Osteobiologics, Inc. has at least 8 other 510(k) clearances on record.