NIKO CORPECTOMY SPACER

Spinal Vertebral Body Replacement Device

GLOBUS MEDICAL INC.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Niko Corpectomy Spacer.

Pre-market Notification Details

• Device ID: K072465
• 510k Number: K072465
• Device Name: NIKO CORPECTOMY SPACER
• Classification: Spinal Vertebral Body Replacement Device
• 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: MQP
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-09-04
• Decision Date: 2007-10-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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