510(k) K123225

BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60 by Aap Biomaterials GmbH & Co. KG — Product Code LOD

K123225 is an FDA 510(k) premarket notification submitted by Aap Biomaterials GmbH & Co. KG for the device "BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60". The FDA issued a decision of Substantially Equivalent on Mar 15, 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.