510(k) K090855

EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE by Etex Corp. — Product Code MQV

K090855 is an FDA 510(k) premarket notification submitted by Etex Corp. for the device "EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE". The FDA issued a decision of Substantially Equivalent on September 18, 2009. 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.