Cortina™ [MAX] Lumbar Cage System

Intervertebral Fusion Device With Bone Graft, Lumbar

NeuroStructures, Inc.

The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Cortina™ [max] Lumbar Cage System.

Pre-market Notification Details

• Device ID: K192248
• 510k Number: K192248
• Device Name: Cortina™ [MAX] Lumbar Cage System
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: NeuroStructures, Inc. 199 Technology Drive, Suite 110 Irvine, CA 92618
• Contact: Moti Altarac
• Correspondent: Meredith Lee May; Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-08-19
• Decision Date: 2019-11-25
• Summary: summary