510(k) K251161

ANTHEM® Fracture System by Globus Medical, Inc. — Product Code HRS

K251161 is an FDA 510(k) premarket notification submitted by Globus Medical, Inc. for the device "ANTHEM® Fracture System". The FDA issued a decision of Substantially Equivalent on August 18, 2025. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Globus Medical, Inc. has at least 10 other 510(k) clearances on record.