510(k) K090871

CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12 by Bonesupport AB — Product Code MQV

K090871 is an FDA 510(k) premarket notification submitted by Bonesupport AB for the device "CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12". The FDA issued a decision of Substantially Equivalent on September 4, 2009. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Bonesupport AB has at least 6 other 510(k) clearances on record.