BEACON STABILIZATION SYSTEM

Thoracolumbosacral Pedicle Screw System

GLOBUS MEDICAL INC.

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

Pre-market Notification Details

Device IDK073172
510k NumberK073172
Device Name:BEACON STABILIZATION SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon,  PA  19403
ContactKelly J Baker
CorrespondentKelly J Baker
GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon,  PA  19403
Product CodeNKB  
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-13
Decision Date2007-12-13
Summary:summary

NIH GUDID Devices

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