Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System

Intervertebral Fusion Device With Bone Graft, Lumbar

NuVasive, Incorporated

The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System.

Pre-market Notification Details

• Device ID: K173153
• 510k Number: K173153
• Device Name: Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121
• Contact: Michelle Cheung
• Correspondent: Michelle Cheung; NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121
• Product Code: MAX
• 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: 2017-12-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887517995193	K173153	000
00195377006646	K173153	000
00195377006653	K173153	000
00195377006660	K173153	000
00195377006677	K173153	000
00195377006684	K173153	000
00195377006714	K173153	000
00195377006721	K173153	000
00195377006738	K173153	000
00195377006776	K173153	000
00195377024992	K173153	000
00195377025005	K173153	000
00195377025012	K173153	000
00195377025029	K173153	000
00887517056375	K173153	000
00887517056382	K173153	000
00887517056399	K173153	000
00887517056481	K173153	000
00195377006639	K173153	000