VIPER 2 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 2 System.

Pre-market Notification Details

Device IDK090648
510k NumberK090648
Device Name:VIPER 2 SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
ContactFrank Jurczak
CorrespondentFrank Jurczak
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 Received2009-03-11
Decision Date2009-06-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10705034295282 K090648 000
10705034295275 K090648 000
10705034295268 K090648 000
10705034295251 K090648 000
10705034295244 K090648 000
10705034295237 K090648 000
10705034182537 K090648 000

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