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: K182928
• 510k Number: K182928
• 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: Raphael Mcinnis
• Correspondent: Raphael Mcinnis; 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-10-22
• Decision Date: 2019-01-11
• Summary: summary