CITADEL ANTERIOR LUMBAR PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

GLOBUS MEDICAL INC.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Citadel Anterior Lumbar Plate System.

Pre-market Notification Details

• Device ID: K062836
• 510k Number: K062836
• Device Name: CITADEL ANTERIOR LUMBAR PLATE SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• 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: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-09-20
• Decision Date: 2006-12-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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