510(k) K231556

SPECTRUM® GV Bone Cement by Osteoremedies, LLC — Product Code LOD

K231556 is an FDA 510(k) premarket notification submitted by Osteoremedies, LLC for the device "SPECTRUM® GV Bone Cement". The FDA issued a decision of Substantially Equivalent on December 20, 2023. The device falls under product code LOD (Bone Cement), a Class II device regulated under 21 CFR 888.3027. Osteoremedies, LLC has at least 10 other 510(k) clearances on record.