EXPEDIUM SYSTEM, VIPER 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 System, Viper System.

Pre-market Notification Details

• Device ID: K110216
• 510k Number: K110216
• Device Name: EXPEDIUM SYSTEM, VIPER SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Contact: Eugene Bang
• Correspondent: Eugene Bang; 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: 2011-01-25
• Decision Date: 2011-04-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10705034351384	K110216	000
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10705034281445	K110216	000
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10705034282039	K110216	000