INDEPENDENCE® 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® Spacers.

Pre-market Notification Details

• Device ID: K170157
• 510k Number: K170157
• Device Name: INDEPENDENCE® 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: 2017-01-18
• Decision Date: 2017-09-25
• Summary: summary