Arco™-SA Lumbar Cage System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

NeuroStructures, Inc.

The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Arco™-sa Lumbar Cage System.

Pre-market Notification Details

• Device ID: K182195
• 510k Number: K182195
• Device Name: Arco™-SA Lumbar Cage System
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: NeuroStructures, Inc. 16 Technology Drive, Suite 165 Irvine, CA 92618
• Contact: Kathleen Wong
• Correspondent: Meredith Lee May; Empirical Consulting 4628 Northpark Drive Colorado Springs, CO 80918
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-08-14
• Decision Date: 2018-11-09
• Summary: summary