510(k) K203278

INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers by Globus Medical, Inc. — Product Code MAX

K203278 is an FDA 510(k) premarket notification submitted by Globus Medical, Inc. for the device "INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers". The FDA issued a decision of Substantially Equivalent on Feb 2, 2021. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Globus Medical, Inc. has 173 other 510(k) clearances on record.