INDEPENDENCE SPACER

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 Spacer.

Pre-market Notification Details

• Device ID: K082252
• 510k Number: K082252
• Device Name: INDEPENDENCE SPACER
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403
• Contact: Kelly Baker
• Correspondent: Kelly Baker; GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER 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: 2008-08-08
• Decision Date: 2008-11-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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