MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM

Appliance, Fixation, Spinal Interlaminal

MEDTRONIC SOFAMOR DANEK

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Modification To Vertex Reconstruction System.

Pre-market Notification Details

• Device ID: K042524
• 510k Number: K042524
• Device Name: MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• 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: KWP
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-09-17
• Decision Date: 2004-10-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885074175065	K042524	000
00885074175058	K042524	000
00885074175027	K042524	000
00885074175003	K042524	000