ANTHEM Fracture System

Plate, Fixation, Bone

Globus Medical Inc.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Anthem Fracture System.

Pre-market Notification Details

Device IDK202496
510k NumberK202496
Device Name:ANTHEM Fracture System
ClassificationPlate, Fixation, Bone
Applicant Globus Medical Inc. 2560 General Armistead Ave. Audubon,  PA  19403
ContactJennifer Antonacci
CorrespondentJennifer Antonacci
Globus Medical Inc. 2560 General Armistead Ave. Audubon,  PA  19403
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-31
Decision Date2020-10-29

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