VIPER SYSTEMS

Thoracolumbosacral Pedicle Screw System

JOHNSON & JOHNSON

The following data is part of a premarket notification filed by Johnson & Johnson with the FDA for Viper Systems.

Pre-market Notification Details

Device IDK111571
510k NumberK111571
Device Name:VIPER SYSTEMS
ClassificationThoracolumbosacral Pedicle Screw System
Applicant JOHNSON & JOHNSON 325 PARAMOUNT DR. Raynham,  MA  02767 -0151
ContactDaphney Germain-kolawole
CorrespondentDaphney Germain-kolawole
JOHNSON & JOHNSON 325 PARAMOUNT DR. Raynham,  MA  02767 -0151
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-06
Decision Date2011-07-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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Trademark Results [VIPER SYSTEMS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VIPER SYSTEMS
VIPER SYSTEMS
76373907 not registered Dead/Abandoned
American ToolTech International, Inc.
2002-02-22

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