Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System

Appliance, Fixation, Spinal Intervertebral Body

Spinal Elements, Inc.

The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System.

Pre-market Notification Details

• Device ID: K201029
• 510k Number: K201029
• Device Name: Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Spinal Elements, Inc. 3115 Melrose Dr. Suite 200 Carlsbad, CA 92010
• Contact: Julie Lamothe
• Correspondent: Julie Lamothe; Spinal Elements, Inc. 3115 Melrose Dr. Suite 200 Carlsbad, CA 92010
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-04-20
• Decision Date: 2020-06-17