VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT 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 Vertex Reconstruction System, Vertex Select Reconstruction System.

Pre-market Notification Details

• Device ID: K090714
• 510k Number: K090714
• Device Name: VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Melisa Lansky
• Correspondent: Melisa Lansky; 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: 2009-03-18
• Decision Date: 2009-04-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994453143	K090714	000
00613994244512	K090714	000
00613994244529	K090714	000
00613994245274	K090714	000
00613994245298	K090714	000
00613994245304	K090714	000
00613994448811	K090714	000
00613994448828	K090714	000
00613994448835	K090714	000
00613994453129	K090714	000
00613994453136	K090714	000
00613994244505	K090714	000