UNIFY DYNAMIC ANTERIOR CERVICAL 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 Unify Dynamic Anterior Cervical Plate System.

Pre-market Notification Details

• Device ID: K121049
• 510k Number: K121049
• Device Name: UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403
• Contact: Meriam Youssef
• Correspondent: Meriam Youssef; GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-04-06
• Decision Date: 2012-06-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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