510(k) K092773

CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST by Tecres S.P.A. — Product Code LOD

K092773 is an FDA 510(k) premarket notification submitted by Tecres S.P.A. for the device "CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST". The FDA issued a decision of Substantially Equivalent on November 24, 2009. The device falls under product code LOD (Bone Cement), a Class II device regulated under 21 CFR 888.3027. Tecres S.P.A. has at least 10 other 510(k) clearances on record.