CD HORIZON SPINAL SYSTEM

Thoracolumbosacral Pedicle Screw System

MEDTRONIC SOFAMOR DANEK, INC.

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

Pre-market Notification Details

• Device ID: K102807
• 510k Number: K102807
• Device Name: CD HORIZON SPINAL SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Chris Mckee
• Correspondent: Chris Mckee; MEDTRONIC SOFAMOR DANEK, 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: Se - With Limitations (SESU)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-09-28
• Decision Date: 2010-11-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994846594	K102807	000
00613994609618	K102807	000
00613994609601	K102807	000
00613994609595	K102807	000
00613994609588	K102807	000
00613994609571	K102807	000
00613994609526	K102807	000
00613994609519	K102807	000
00613994609502	K102807	000
00613994609496	K102807	000
00613994609489	K102807	000
00613994609472	K102807	000
00613994609465	K102807	000
00613994609458	K102807	000
00613994609625	K102807	000
00613994609632	K102807	000
00613994610409	K102807	000
00613994610393	K102807	000
00613994610386	K102807	000
00613994610379	K102807	000
00613994610362	K102807	000
00613994610355	K102807	000
00613994610270	K102807	000
00613994609694	K102807	000
00613994609687	K102807	000
00613994609670	K102807	000
00613994609663	K102807	000
00613994609656	K102807	000
00613994609649	K102807	000
00613994609441	K102807	000