CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION

Appliance, Fixation, Spinal Interlaminal

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, 4.5 Rod For Posterior Application.

Pre-market Notification Details

• Device ID: K010181
• 510k Number: K010181
• Device Name: CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Richard Treharne
• Correspondent: Richard Treharne; MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-01-19
• Decision Date: 2001-06-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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