510(k) K182260

PALACOS MV by Heraeus Medical GmbH — Product Code LOD

K182260 is an FDA 510(k) premarket notification submitted by Heraeus Medical GmbH for the device "PALACOS MV". The FDA issued a decision of Substantially Equivalent on September 17, 2018. 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.