Vertu® & Vertu® Ti-Bond And Crystal® & Crystal® Ti-Bond Cervical Interbody System

Intervertebral Fusion Device With Integrated Fixation, Cervical

Spinal Elements Inc.

The following data is part of a premarket notification filed by Spinal Elements Inc. with the FDA for Vertu® & Vertu® Ti-bond And Crystal® & Crystal® Ti-bond Cervical Interbody System.

Pre-market Notification Details

• Device ID: K153352
• 510k Number: K153352
• Device Name: Vertu® & Vertu® Ti-Bond And Crystal® & Crystal® Ti-Bond Cervical Interbody System
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• Applicant: Spinal Elements Inc. 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010
• Contact: Cecilia Silva
• Correspondent: Julie Lamothe; Spinal Elements Inc. 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010
• Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-11-20
• Decision Date: 2016-08-01
• Summary: summary