VERTEX™ Reconstruction System

Posterior Cervical Screw System

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.

Pre-market Notification Details

• Device ID: K180851
• 510k Number: K180851
• Device Name: VERTEX™ Reconstruction System
• Classification: Posterior Cervical Screw System
• Applicant: Medtronic Sofamor Danek USA, Inc 1800 Pyramid Place Memphis, TN 38132
• Contact: Ankit K Shah
• Correspondent: Ankit K Shah; Medtronic Sofamor Danek USA, Inc 1800 Pyramid Place Memphis, TN 38132
• Product Code: NKG
• CFR Regulation Number: 888.3075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-04-02
• Decision Date: 2018-04-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994641915	K180851	000
00613994641663	K180851	000
00613994641670	K180851	000
00613994641892	K180851	000
00613994641908	K180851	000
00613994666642	K180851	000
00613994666970	K180851	000
00613994666987	K180851	000
00643169101333	K180851	000
00643169101357	K180851	000
00643169101371	K180851	000
00643169101463	K180851	000
00613994641656	K180851	000