REVLOK FENESTRATED SCREW 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 Revlok Fenestrated Screw System.

Pre-market Notification Details

• Device ID: K110280
• 510k Number: K110280
• Device Name: REVLOK FENESTRATED SCREW 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: KWQ
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Se - With Limitations (SESU)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-01-31
• Decision Date: 2011-07-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00849044070002	K110280	000
00849044069884	K110280	000
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