TransContinental® M Spacers And InterContinental® Plate-Spacers

Intervertebral Fusion Device With Integrated Fixation, Lumbar

GLOBUS MEDICAL INC.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Transcontinental® M Spacers And Intercontinental® Plate-spacers.

Pre-market Notification Details

• Device ID: K161223
• 510k Number: K161223
• Device Name: TransContinental® M Spacers And InterContinental® Plate-Spacers
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• 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: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-04-29
• Decision Date: 2016-07-15
• Summary: summary