VERTEX RECONSTRUCTION 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 Reconstruction System, Vertex Select Reconstruction System.

Pre-market Notification Details

• Device ID: K123656
• 510k Number: K123656
• Device Name: VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Claire Evans
• Correspondent: Claire Evans; 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: 2012-11-28
• Decision Date: 2013-02-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169056169	K123656	000
00643169056305	K123656	000
00643169056312	K123656	000
00643169056329	K123656	000
00643169056336	K123656	000
00643169056343	K123656	000
00643169056350	K123656	000
00643169056367	K123656	000
00643169056374	K123656	000
00643169056398	K123656	000
00643169056299	K123656	000
00643169056282	K123656	000
00643169056275	K123656	000
00643169056183	K123656	000
00643169056190	K123656	000
00643169056206	K123656	000
00643169056213	K123656	000
00643169056220	K123656	000
00643169056237	K123656	000
00643169056244	K123656	000
00643169056251	K123656	000
00643169056268	K123656	000
00643169056404	K123656	000
00643169056411	K123656	000
00643169056572	K123656	000
00643169056589	K123656	000
00643169056596	K123656	000
00643169096912	K123656	000
00643169096929	K123656	000
00643169096936	K123656	000
00643169096943	K123656	000
00643169098329	K123656	000
00643169098336	K123656	000
00643169056565	K123656	000
00643169056558	K123656	000
00643169056541	K123656	000
00643169056428	K123656	000
00643169056459	K123656	000
00643169056473	K123656	000
00643169056480	K123656	000
00643169056497	K123656	000
00643169056503	K123656	000
00643169056510	K123656	000
00643169056527	K123656	000
00643169056534	K123656	000
00643169098343	K123656	000