SOVEREIGN® Spinal System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

MEDTRONIC SOFAMOR DANEK USA, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Sovereign® Spinal System.

Pre-market Notification Details

• Device ID: K162680
• 510k Number: K162680
• Device Name: SOVEREIGN® Spinal System
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Kanesha Hines
• Correspondent: Kanesha Hines; MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-09-26
• Decision Date: 2016-12-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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