510(k) K123081

BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40 by Aap Biomaterials GmbH & Co. KG — Product Code LOD

K123081 is an FDA 510(k) premarket notification submitted by Aap Biomaterials GmbH & Co. KG for the device "BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40". The FDA issued a decision of Substantially Equivalent on Mar 7, 2013. The device falls under product code LOD (Bone Cement), a Class II device regulated under 21 CFR 888.3027. Aap Biomaterials GmbH & Co. KG has 1 other 510(k) clearance on record.