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: K122862
• 510k Number: K122862
• Device Name: CD HORIZON SPINAL SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Chris Mckee
• Correspondent: Chris Mckee; 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: Se - With Limitations (SESU)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-09-17
• Decision Date: 2012-10-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169177024	K122862	000
00643169217188	K122862	000
00643169217195	K122862	000
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00643169217263	K122862	000
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00643169177048	K122862	000
00643169177055	K122862	000
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