REVERE 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 Revere Stabilization System.

Pre-market Notification Details

• Device ID: K093294
• 510k Number: K093294
• Device Name: REVERE STABILIZATION SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403
• Contact: Kelly J Baker, Ph.d
• Correspondent: Kelly J Baker, Ph.d; 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
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-10-21
• Decision Date: 2010-02-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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