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: K143633
• 510k Number: K143633
• 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
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• Subsequent Product Code: OSH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-12-22
• Decision Date: 2015-01-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889095349016	K143633	000
00889095348927	K143633	000
00889095347937	K143633	000