510(k) K072327

CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON by Regeneration Technologies, Inc. — Product Code MQV

K072327 is an FDA 510(k) premarket notification submitted by Regeneration Technologies, Inc. for the device "CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON". The FDA issued a decision of Substantially Equivalent on October 24, 2007. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Regeneration Technologies, Inc. has at least 10 other 510(k) clearances on record.