510(k) K211163

Bone Cement Genta, Bone Cement HV, Bone Cement LV by Tecres S.P.A. — Product Code LOD

K211163 is an FDA 510(k) premarket notification submitted by Tecres S.P.A. for the device "Bone Cement Genta, Bone Cement HV, Bone Cement LV". The FDA issued a decision of Substantially Equivalent on January 9, 2023. 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.