510(k) K202475

PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G by Heraeus Medical GmbH — Product Code LOD

K202475 is an FDA 510(k) premarket notification submitted by Heraeus Medical GmbH for the device "PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G". The FDA issued a decision of Substantially Equivalent on November 23, 2020. The device falls under product code LOD (Bone Cement), a Class II device regulated under 21 CFR 888.3027. Heraeus Medical GmbH has at least 10 other 510(k) clearances on record.