ASSURE® 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 Assure® Anterior Cervical Plate System.

Pre-market Notification Details

• Device ID: K183056
• 510k Number: K183056
• Device Name: ASSURE® Anterior Cervical Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Globus Medical, Inc. Valley Forge Business Center 2560 General Armistead Avenue Audubon, PA 19403
• Contact: Kelly J. Baker
• Correspondent: Kelly J. Baker; Globus Medical, Inc. Valley Forge Business Center 2560 General Armistead Avenue 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: 2018-11-02
• Decision Date: 2019-04-19