510(k) K063685

OPTECURE; OPTECURE + CCC by Exactech, Inc. — Product Code MBP

K063685 is an FDA 510(k) premarket notification submitted by Exactech, Inc. for the device "OPTECURE; OPTECURE + CCC". The FDA issued a decision of Substantially Equivalent on June 7, 2007. The device falls under product code MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)), a Class II device regulated under 21 CFR 888.3045. Exactech, Inc. has at least 10 other 510(k) clearances on record.