COALITION® And COALITION® TPS, COALITION MIS® And COALITION MIS® TPS, COALITION AGX® And COALITION AGX® TPS

Intervertebral Fusion Device With Bone Graft, Cervical

Globus Medical Inc.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Coalition® And Coalition® Tps, Coalition Mis® And Coalition Mis® Tps, Coalition Agx® And Coalition Agx® Tps.

Pre-market Notification Details

• Device ID: K173115
• 510k Number: K173115
• Device Name: COALITION® And COALITION® TPS, COALITION MIS® And COALITION MIS® TPS, COALITION AGX® And COALITION AGX® TPS
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403
• Contact: Kelly J. Baker
• Correspondent: Kelly J. Baker, Ph.d.; Globus Medical Inc. 2560 General Armistead Avenue Audubon, PA 19403
• Product Code: ODP
• Subsequent Product Code: KWQ
• Subsequent Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-09-29
• Decision Date: 2017-12-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889095390001	K173115	000
00889095389999	K173115	000