510(k) K210125

BonOs HV Genta, BonOs MV Genta, BonOs LV Genta by Osartis GmbH — Product Code LOD

K210125 is an FDA 510(k) premarket notification submitted by Osartis GmbH for the device "BonOs HV Genta, BonOs MV Genta, BonOs LV Genta". The FDA issued a decision of Substantially Equivalent on March 19, 2021. The device falls under product code LOD (Bone Cement), a Class II device regulated under 21 CFR 888.3027. Osartis GmbH has at least 5 other 510(k) clearances on record.