SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Sp

Intervertebral Fusion Device With Bone Graft, Lumbar

GLOBUS MEDICAL INC.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Sustain® R Spacers, Patriot® Spacers, Caliber® Spacers, Rise® Spacers, Coalition® Spacers, Coalition Agx™ Spacers, Independence® Spacers, Fortify®-r Corpectomy Spacers, Fortify® I-r Corpectomy Spacers, Xpand®-r Corpectomy Spacers, Niko® Corpectomy Sp.

Pre-market Notification Details

Device IDK152022
510k NumberK152022
Device Name:SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Sp
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant GLOBUS MEDICAL INC. VALLEY FORGE BUSINESS CENTER 2560 GENERAL ARMISTEAD AVE. Audubon,  PA  19403
ContactKelly J. Baker
CorrespondentKelly J. Baker
GLOBUS MEDICAL INC. VALLEY FORGE BUSINESS CENTER 2560 GENERAL ARMISTEAD AVE. Audubon,  PA  19403
Product CodeMAX  
Subsequent Product CodeMQP
Subsequent Product CodeODP
Subsequent Product CodeOVD
Subsequent Product CodeOVE
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-21
Decision Date2017-02-22
Summary:summary

Trademark Results [SUSTAIN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SUSTAIN
SUSTAIN
98625132 not registered Live/Pending
Cambia Health Solutions, Inc.
2024-06-28
SUSTAIN
SUSTAIN
98355553 not registered Live/Pending
Nalge Nunc International Corporation
2024-01-12
SUSTAIN
SUSTAIN
98047212 not registered Live/Pending
Valdese Weavers, LLC
2023-06-16
SUSTAIN
SUSTAIN
98004507 not registered Live/Pending
Levin, Phillip
2023-05-19
SUSTAIN
SUSTAIN
97588747 not registered Live/Pending
Scebold, Chad R
2022-09-13
SUSTAIN
SUSTAIN
97550131 not registered Live/Pending
Nancy Rahnama MD APC
2022-08-16
SUSTAIN
SUSTAIN
97358635 not registered Live/Pending
AWI LICENSING LLC
2022-04-12
SUSTAIN
SUSTAIN
97174091 not registered Live/Pending
ICL Europe Cooperatief U.A.
2021-12-15
SUSTAIN
SUSTAIN
97015152 not registered Live/Pending
The Dow Chemical Company
2021-09-07
SUSTAIN
SUSTAIN
90859596 not registered Live/Pending
Roi Venture Group LLC
2021-07-31
SUSTAIN
SUSTAIN
90222473 not registered Live/Pending
Single Use Solutions, LLC
2020-09-29
SUSTAIN
SUSTAIN
90127777 not registered Live/Pending
Canidae, LLC
2020-08-20

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