Mercury® Spinal System, Overwatch® 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® Spinal System, Overwatch® Spinal System.

Pre-market Notification Details

• Device ID: K191576
• 510k Number: K191576
• Device Name: Mercury® Spinal System, Overwatch® 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
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-06-14
• Decision Date: 2019-09-16
• Summary: summary