CD HORIZON™ Spinal System

Posterior Metal/polymer Spinal System, Fusion

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: K203678
• 510k Number: K203678
• Device Name: CD HORIZON™ Spinal System
• Classification: Posterior Metal/polymer Spinal System, Fusion
• Applicant: Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis, TN 38132
• Contact: Madhuvanthi Soundirarajan
• Correspondent: Madhuvanthi Soundirarajan; Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis, TN 38132
• Product Code: NQP
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-12-17
• Decision Date: 2021-01-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00763000404987	K203678	000
00763000585440	K203678	000
00763000585457	K203678	000
00763000585464	K203678	000
00763000370923	K203678	000
00763000370930	K203678	000
00763000370947	K203678	000
00763000370954	K203678	000
00763000404956	K203678	000
00763000404963	K203678	000
00763000404970	K203678	000
00763000585433	K203678	000