510(k) K083033

VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE by Orthovita, Inc. — Product Code MQV

K083033 is an FDA 510(k) premarket notification submitted by Orthovita, Inc. for the device "VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE". The FDA issued a decision of Substantially Equivalent on November 6, 2008. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Orthovita, Inc. has at least 10 other 510(k) clearances on record.