X-MESH EXPANDABLE CAGE SYSTEM

Spinal Vertebral Body Replacement Device

DEPUY SPINE, INC.

The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for X-mesh Expandable Cage System.

Pre-market Notification Details

• Device ID: K080568
• 510k Number: K080568
• Device Name: X-MESH EXPANDABLE CAGE SYSTEM
• Classification: Spinal Vertebral Body Replacement Device
• Applicant: DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Contact: Hande Tufan
• Correspondent: Hande Tufan; DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Product Code: MQP
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-02-29
• Decision Date: 2008-05-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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