SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Sp

Intervertebral Fusion Device With Bone Graft, Lumbar

GLOBUS MEDICAL INC.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Sustain® R Spacers, Patriot® Spacers, Caliber® Spacers, Rise® Spacers, Coalition® Spacers, Coalition Agx™ Spacers, Independence® Spacers, Fortify®-r Corpectomy Spacers, Fortify® I-r Corpectomy Spacers, Xpand®-r Corpectomy Spacers, Niko® Corpectomy Sp.

Pre-market Notification Details

• Device ID: K152022
• 510k Number: K152022
• Device Name: SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Sp
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: GLOBUS MEDICAL INC. VALLEY FORGE BUSINESS CENTER 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403
• Contact: Kelly J. Baker
• Correspondent: Kelly J. Baker; GLOBUS MEDICAL INC. VALLEY FORGE BUSINESS CENTER 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403
• Product Code: MAX
• Subsequent Product Code: MQP
• Subsequent Product Code: ODP
• Subsequent Product Code: OVD
• Subsequent Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-07-21
• Decision Date: 2017-02-22
• Summary: summary