510(k) K040454

BIOFILL BONE VOID FILLER by Scient'X — Product Code MQV

K040454 is an FDA 510(k) premarket notification submitted by Scient'X for the device "BIOFILL BONE VOID FILLER". The FDA issued a decision of Substantially Equivalent on May 7, 2004. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Scient'X has at least 10 other 510(k) clearances on record.