NuVasive® Modulus XLIF Interbody 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 Nuvasive® Modulus Xlif Interbody System.

Pre-market Notification Details

• Device ID: K172123
• 510k Number: K172123
• Device Name: NuVasive® Modulus XLIF Interbody System
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121
• Contact: Cynthia Adams
• Correspondent: Cynthia Adams; NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121
• Product Code: MAX
• Subsequent Product Code: OVD
• Subsequent Product Code: PHM
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-07-14
• Decision Date: 2017-10-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887517913425	K172123	000
00887517913418	K172123	000
00887517913401	K172123	000
00887517913227	K172123	000
00887517913210	K172123	000
00887517913203	K172123	000
00887517022370	K172123	000