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: K142591
• 510k Number: K142591
• Device Name: CD HORIZON Spinal System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Lila Joe
• Correspondent: Lila Joe; 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: 2014-09-15
• Decision Date: 2014-12-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169429062	K142591	000
00763000794668	K142591	000
00763000794620	K142591	000
00763000794606	K142591	000
00763000794576	K142591	000
00763000794521	K142591	000
00763000794491	K142591	000
00763000794460	K142591	000
00763000794453	K142591	000
00763000794415	K142591	000
00763000794477	K142591	000
00763000794439	K142591	000
00763000794422	K142591	000
00763000794675	K142591	000
00763000794682	K142591	000
00763000802134	K142591	000
00643169428959	K142591	000
00643169428928	K142591	000
00643169428898	K142591	000
00643169428812	K142591	000
00643169428775	K142591	000
00643169428751	K142591	000
00643169428720	K142591	000
00643169428676	K142591	000
00643169428645	K142591	000
00643169428614	K142591	000
00643169428560	K142591	000
00643169428836	K142591	000
00643169428607	K142591	000
00763000794507	K142591	000