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: K173249
• 510k Number: K173249
• Device Name: CD HORIZON™ Spinal System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Pl Memphis, TN 38132
• Contact: Ankit K. Shah
• Correspondent: Ankit K. Shah; Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Pl Memphis, TN 38132
• 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: 2017-10-10
• Decision Date: 2018-03-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169754638	K173249	000