H-LINK INTEGRATED ROD

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 H-link Integrated Rod.

Pre-market Notification Details

Device IDK073517
510k NumberK073517
Device Name:H-LINK INTEGRATED ROD
ClassificationThoracolumbosacral Pedicle Screw System
Applicant GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon,  PA  19403
ContactKelly J Baker
CorrespondentKelly J Baker
GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon,  PA  19403
Product CodeNKB  
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-14
Decision Date2008-01-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00849044023299 K073517 000
00849044023176 K073517 000

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