510(k) K250760

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

K250760 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 April 2, 2025. 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.