510(k) K061499

OSFERION by Olympus America, Inc. — Product Code MQV

K061499 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OSFERION". The FDA issued a decision of Substantially Equivalent on January 26, 2007. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Olympus America, Inc. has at least 10 other 510(k) clearances on record.