EXPEDIUM 4.5MM SPINE SYSTEM

Thoracolumbosacral Pedicle Screw System

DEPUY SPINE, INC.

The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Expedium 4.5mm Spine System.

Pre-market Notification Details

• Device ID: K081252
• 510k Number: K081252
• Device Name: EXPEDIUM 4.5MM SPINE SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Contact: Christopher Klaczyk
• Correspondent: Christopher Klaczyk; DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-05-02
• Decision Date: 2008-05-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10705034103853	K081252	000
10705034105758	K081252	000
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