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: K162494
• 510k Number: K162494
• Device Name: CD HORIZON® Spinal System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Justin O'connor
• Correspondent: Justin O'connor; MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis, TN 38132
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• Subsequent Product Code: OSH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-09-07
• Decision Date: 2016-10-04
• Summary: summary