MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM

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 Modification To Vertex Reconstruction System.

Pre-market Notification Details

• Device ID: K023555
• 510k Number: K023555
• Device Name: MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• 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: KWP
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-10-23
• Decision Date: 2002-11-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00721902060649	K023555	000
00721902060571	K023555	000