MODIFICATION TO CD HORIZON SPINAL SYSTEM

Thoracolumbosacral Pedicle Screw System

MEDTRONIC SOFAMOR DANEK

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Modification To Cd Horizon Spinal System.

Pre-market Notification Details

• Device ID: K063417
• 510k Number: K063417
• Device Name: MODIFICATION TO CD HORIZON SPINAL SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Lee Grant
• Correspondent: Lee Grant; MEDTRONIC SOFAMOR DANEK 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: NQP
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-11-13
• Decision Date: 2007-01-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994235619	K063417	000
00613994235602	K063417	000
00613994235596	K063417	000
00613994235589	K063417	000
00613994234605	K063417	000