MODIFICATION TO: CD HORIZON SPINAL SYSTEM

Orthosis, Spinal Pedicle Fixation

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: K040583
• 510k Number: K040583
• Device Name: MODIFICATION TO: CD HORIZON SPINAL SYSTEM
• Classification: Orthosis, Spinal Pedicle Fixation
• Applicant: MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Richard Treharne
• Correspondent: Richard Treharne; MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132
• Product Code: MNI
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• Subsequent Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-03-05
• Decision Date: 2004-03-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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