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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K182375
Device Name CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®
Applicant
Globus Medical, Inc.
2560 General Armistead Ave.
Audubon,  PA  19403
Applicant Contact Kelly J. Baker
Correspondent
Globus Medical, Inc.
2560 General Armistead Ave.
Audubon,  PA  19403
Correspondent Contact Kelly J. Baker
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
HAW   KWP   OLO  
Date Received08/31/2018
Decision Date 04/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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