CREO® Stabilization System, REVERE® Stabilization System

Growing Rod 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, Revere® Stabilization System.

Pre-market Notification Details

• Device ID: K181068
• 510k Number: K181068
• Device Name: CREO® Stabilization System, REVERE® Stabilization System
• Classification: Growing Rod 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: PGM
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-04-23
• Decision Date: 2018-06-29
• Summary: summary