SILC® Fixation System

Bone Fixation Cerclage, Sublaminar

Globus Medical Inc.

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

Pre-market Notification Details

• Device ID: K172417
• 510k Number: K172417
• Device Name: SILC® Fixation System
• Classification: Bone Fixation Cerclage, Sublaminar
• Applicant: Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403
• Contact: Lori Burns
• Correspondent: Lori Burns; Globus Medical Inc. 2560 General Armistead Avenue Audubon, PA 19403
• Product Code: OWI
• CFR Regulation Number: 888.3010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-08-10
• Decision Date: 2017-10-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889095493252	K172417	000
00889095493191	K172417	000
00193982146160	K172417	000
00193982146153	K172417	000