VIPER 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 Viper Spine System.

Pre-market Notification Details

Device IDK102701
510k NumberK102701
Device Name:VIPER SPINE SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
ContactKevin G Stevens
CorrespondentKevin G Stevens
DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-20
Decision Date2010-10-20
Summary:summary

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