CREO® Stabilization System

Thoracolumbosacral Pedicle Screw System

Globus Medical Inc.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Creo® Stabilization System.

Pre-market Notification Details

• Device ID: K180210
• 510k Number: K180210
• Device Name: CREO® Stabilization System
• Classification: Thoracolumbosacral Pedicle Screw System
• 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: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-01-24
• Decision Date: 2018-04-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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