510(k) K083279

CALTRIX RESORBABLE BONE VOID FILLER by Ag Digital Technology Corp. — Product Code MQV

K083279 is an FDA 510(k) premarket notification submitted by Ag Digital Technology Corp. for the device "CALTRIX RESORBABLE BONE VOID FILLER". The FDA issued a decision of Substantially Equivalent on January 28, 2009. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Ag Digital Technology Corp. has at least 3 other 510(k) clearances on record.