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: K022015
• 510k Number: K022015
• 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: 2002-06-20
• Decision Date: 2002-07-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994295323	K022015	000
00721902180828	K022015	000
00721902180842	K022015	000
00721902180866	K022015	000
00721902180873	K022015	000
00721902293498	K022015	000
00721902293504	K022015	000
00721902293511	K022015	000
00721902293528	K022015	000
00721902293559	K022015	000
00721902293580	K022015	000
00721902037863	K022015	000