Ortus™ Expandable Lumbar Interbody Fusion System

Intervertebral Fusion Device With Bone Graft, Lumbar

Atlas Spine, Inc.

The following data is part of a premarket notification filed by Atlas Spine, Inc. with the FDA for Ortus™ Expandable Lumbar Interbody Fusion System.

Pre-market Notification Details

• Device ID: K172334
• 510k Number: K172334
• Device Name: Ortus™ Expandable Lumbar Interbody Fusion System
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Atlas Spine, Inc. 1555 Jupiter Park Drive, Suite 1 Jupiter, FL 33458
• Contact: Thomas Smith
• Correspondent: Thomas Smith; Atlas Spine, Inc. 1555 Jupiter Park Drive, Suite 1 Jupiter, FL 33458
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-08-02
• Decision Date: 2017-10-25