SPINAL MESH SYSTEM

Spinal Vertebral Body Replacement Device

MEDTRONIC SOFAMOR DANEK, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Spinal Mesh System.

Pre-market Notification Details

• Device ID: K011406
• 510k Number: K011406
• Device Name: SPINAL MESH SYSTEM
• Classification: Spinal Vertebral Body Replacement Device
• Applicant: MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Richard Treharne
• Correspondent: Richard Treharne; MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Product Code: MQP
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-05-08
• Decision Date: 2001-12-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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