VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM

Appliance, Fixation, Spinal Interlaminal

MEDTRONIC SOFAMOR DANEK USA, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Vertex Recontruction System, Vertex Select Reconstruction System.

Pre-market Notification Details

• Device ID: K082728
• 510k Number: K082728
• Device Name: VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Melisa Lansky
• Correspondent: Melisa Lansky; MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Product Code: KWP
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-09-18
• Decision Date: 2009-01-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994901187	K082728	000
00613994387608	K082728	000
00613994387592	K082728	000
00613994387585	K082728	000
00613994254986	K082728	000
00613994254979	K082728	000
00613994245472	K082728	000
00613994245410	K082728	000
00613994245083	K082728	000
00613994244444	K082728	000
00613994239280	K082728	000
00613994239273	K082728	000
00613994239266	K082728	000
00613994394477	K082728	000
00613994394484	K082728	000
00613994514509	K082728	000
00613994458988	K082728	000
00613994458971	K082728	000
00613994458940	K082728	000
00613994458933	K082728	000
00613994458926	K082728	000
00613994458919	K082728	000
00613994454041	K082728	000
00613994453167	K082728	000
00613994453150	K082728	000
00613994448743	K082728	000
00613994394491	K082728	000
00613994239259	K082728	000