REVOLVE 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 Revolve Stabilization System.

Pre-market Notification Details

• Device ID: K083416
• 510k Number: K083416
• Device Name: REVOLVE STABILIZATION SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403
• Contact: Kelly J Baker
• Correspondent: Kelly J Baker; GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403
• Product Code: NKB
• Subsequent Product Code: KWP
• 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: 2008-11-18
• Decision Date: 2009-01-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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