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: K162379
• 510k Number: K162379
• Device Name: CD HORIZON® Spinal System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: MEDTRONIC SOFAMOR DANEK USA, INC. 1800 Pyramid Place Memphis, TN 38132
• Contact: Nathaniel Hendricks
• Correspondent: Becky Ronner; 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-24
• Decision Date: 2016-11-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169792029	K162379	000
00643169761957	K162379	000
00643169761940	K162379	000
00643169761933	K162379	000
00643169761926	K162379	000
00643169761919	K162379	000
00643169761902	K162379	000
00643169761896	K162379	000
00643169761889	K162379	000
00643169761872	K162379	000
00643169761865	K162379	000
00643169761629	K162379	000
00643169761964	K162379	000
00643169761971	K162379	000
00643169792012	K162379	000
00643169792005	K162379	000
00643169791992	K162379	000
00643169791985	K162379	000
00643169791978	K162379	000
00643169763104	K162379	000
00643169763098	K162379	000
00643169762015	K162379	000
00643169762008	K162379	000
00643169761995	K162379	000
00643169761988	K162379	000
00643169761612	K162379	000