510(k) K241564

Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS by Baxter Healthcare Corporation — Product Code MQV

K241564 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS". The FDA issued a decision of Substantially Equivalent on August 2, 2024. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Baxter Healthcare Corporation has at least 10 other 510(k) clearances on record.