510(k) K051615

STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES by Regeneration Technologies, Inc. — Product Code MQV

K051615 is an FDA 510(k) premarket notification submitted by Regeneration Technologies, Inc. for the device "STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES". The FDA issued a decision of Substantially Equivalent on August 15, 2005. 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.