510(k) K063346

PRO OSTEON 500R by Ebi, L.P. — Product Code MQV

K063346 is an FDA 510(k) premarket notification submitted by Ebi, L.P. for the device "PRO OSTEON 500R". The FDA issued a decision of Substantially Equivalent on April 18, 2007. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Ebi, L.P. has at least 10 other 510(k) clearances on record.