Mercury® II Spinal System

Thoracolumbosacral Pedicle Screw System

Spinal Elements, Inc.

The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Mercury® Ii Spinal System.

Pre-market Notification Details

• Device ID: K222516
• 510k Number: K222516
• Device Name: Mercury® II Spinal System
• Classification: Thoracolumbosacral Pedicle Screw System
• 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: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: OLO
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-08-19
• Decision Date: 2022-12-01