510(k) clearance

ANTHEM™ Fracture System

FDA 510(k) source

510(k) number

K262779

Applicant

Globus Medical, Inc.

Decision date

Oct 23, 2026

Date received

Aug 5, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

HRS

Device type

Plate, Fixation, Bone

Device class

Class II

Regulation

21 CFR 888.3030

Advisory committee

Orthopedic

Statement or summary

Summary

Third party

N

Location

Audubon, PA, US