510(k) K072355

OSSIFUSE BONE SUBSTITUTE MATERIAL by Etex Corp. — Product Code MQV

K072355 is an FDA 510(k) premarket notification submitted by Etex Corp. for the device "OSSIFUSE BONE SUBSTITUTE MATERIAL". The FDA issued a decision of Substantially Equivalent on September 26, 2007. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Etex Corp. has at least 10 other 510(k) clearances on record.