EXPEDIUM ANTERIOR SPINE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

DEPUY SPINE, INC.

The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Expedium Anterior Spine System.

Pre-market Notification Details

• Device ID: K041205
• 510k Number: K041205
• Device Name: EXPEDIUM ANTERIOR SPINE SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Contact: Jennifer Mooney
• Correspondent: Jennifer Mooney; DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-05-07
• Decision Date: 2004-08-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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