INDEPENDENCE MIS Spacers

Intervertebral Fusion Device With Integrated Fixation, Lumbar

GLOBUS MEDICAL INC.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Independence Mis Spacers.

Pre-market Notification Details

• Device ID: K160597
• 510k Number: K160597
• Device Name: INDEPENDENCE MIS Spacers
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403
• Contact: Kelly J. Baker
• Correspondent: Kelly J. Baker; GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-03-02
• Decision Date: 2016-08-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889095309959	K160597	000
00889095310177	K160597	000
00889095310191	K160597	000
00889095310214	K160597	000
00889095310238	K160597	000
00889095310252	K160597	000
00889095310467	K160597	000
00889095310481	K160597	000
00889095310504	K160597	000
00889095310528	K160597	000
00889095310160	K160597	000
00889095310146	K160597	000
00889095309973	K160597	000
00889095309997	K160597	000
00889095310016	K160597	000
00889095310030	K160597	000
00889095310054	K160597	000
00889095310061	K160597	000
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00889095310122	K160597	000
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00889095310993	K160597	000
00889095311013	K160597	000
00889095311037	K160597	000
00889095311051	K160597	000
00889095311068	K160597	000
00889095311082	K160597	000
00889095311105	K160597	000
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00889095310597	K160597	000
00889095310610	K160597	000
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00889095310658	K160597	000
00889095310672	K160597	000
00889095310689	K160597	000
00889095310702	K160597	000
00889095310726	K160597	000
00889095311129	K160597	000