Belvedere™ Lateral Plating System

Appliance, Fixation, Spinal Intervertebral Body

NEUROSTRUCTURES, INC.

The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Belvedere™ Lateral Plating System.

Pre-market Notification Details

• Device ID: K153097
• 510k Number: K153097
• Device Name: Belvedere™ Lateral Plating System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: NEUROSTRUCTURES, INC. 16 TECHNOLOGY DR. SUITE 165 Irvine, CA 92618
• Contact: Moti Altarac
• Correspondent: Kenneth C Maxwell; EMPIRICAL TESTING CORPORATION 4628 NORTHPARK DRIVE Colorado Springs, CO 80918
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-10-26
• Decision Date: 2016-07-15
• Summary: summary