CD HORIZON SPINAL SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

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: K010249
• 510k Number: K010249
• Device Name: CD HORIZON SPINAL SYSTEM
• Classification: Orthosis, Spondylolisthesis Spinal Fixation
• Applicant: MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Richard W Treharne
• Correspondent: Richard W Treharne; MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Product Code: MNH
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-01-26
• Decision Date: 2001-02-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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