CREO® 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 Creo® Stabilization System.

Pre-market Notification Details

Device IDK180210
510k NumberK180210
Device Name:CREO® 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 CodeKWP
Subsequent Product CodeKWQ
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-24
Decision Date2018-04-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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Trademark Results [CREO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CREO
CREO
98379820 not registered Live/Pending
CREO, LLC
2024-01-29
CREO
CREO
98230551 not registered Live/Pending
Apex Initiative LLC
2023-10-19
CREO
CREO
98146597 not registered Live/Pending
Integreon, Inc.
2023-08-23
CREO
CREO
97674262 not registered Live/Pending
Diamond Technologies Inc
2022-11-11
CREO
CREO
97637835 not registered Live/Pending
Olson, Alexandra L
2022-10-18
CREO
CREO
97637835 not registered Live/Pending
Robberstad, Paige E
2022-10-18
CREO
CREO
97637835 not registered Live/Pending
Olson, Michael D
2022-10-18
CREO
CREO
97338609 not registered Live/Pending
Creo Wear LLC
2022-03-30
CREO
CREO
90086274 not registered Live/Pending
Anthony, Adam Victor
2020-07-31
CREO
CREO
88887153 not registered Live/Pending
Bioactive Ingredients Corporation
2020-04-24
CREO
CREO
87851770 5869194 Live/Registered
Specialized Bicycle Components, Inc.
2018-03-27
CREO
CREO
87778735 not registered Live/Pending
Stray Electrons LLC
2018-01-31

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