510(k) K011726

MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER by Millenium Biologix, Inc. — Product Code MQV

K011726 is an FDA 510(k) premarket notification submitted by Millenium Biologix, Inc. for the device "MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER". The FDA issued a decision of Substantially Equivalent on May 16, 2002. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Millenium Biologix, Inc. has at least 1 other 510(k) clearance on record.