510(k) K032286

CALCIGEN PSI BONE GRAFT SUBSTITUTE by Biomet Orthopedics, Inc. — Product Code MQV

K032286 is an FDA 510(k) premarket notification submitted by Biomet Orthopedics, Inc. for the device "CALCIGEN PSI BONE GRAFT SUBSTITUTE". The FDA issued a decision of Substantially Equivalent on November 20, 2003. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Biomet Orthopedics, Inc. has at least 10 other 510(k) clearances on record.