CD Horizon™ Spinal System

Thoracolumbosacral Pedicle Screw System

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 Cd Horizon™ Spinal System.

Pre-market Notification Details

• Device ID: K201407
• 510k Number: K201407
• Device Name: CD Horizon™ Spinal System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis, TN 38132
• Contact: Usman Rashid
• Correspondent: Raphael Mcinnis; Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis, TN 38132
• Product Code: NKB
• Subsequent Product Code: HBE
• 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: 2020-05-28
• Decision Date: 2020-09-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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