NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF 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® Mlx® – Medial Lateral Expandable Lumbar Interbody System; Nuvasive® Ap Expandable Xlif System.

Pre-market Notification Details

• Device ID: K173025
• 510k Number: K173025
• Device Name: NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF 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
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-09-28
• Decision Date: 2018-02-08
• Summary: summary