VIPER F2 FACET FIXATION SYSTEM

System, Facet Screw Spinal Device

DEPUY SPINE, INC.

The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Viper F2 Facet Fixation System.

Pre-market Notification Details

Device IDK101762
510k NumberK101762
Device Name:VIPER F2 FACET FIXATION SYSTEM
ClassificationSystem, Facet Screw Spinal Device
Applicant DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
ContactFrank Jurczak
CorrespondentFrank Jurczak
DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeMRW  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-22
Decision Date2010-11-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10705034034874 K101762 000
10705034034751 K101762 000
10705034034959 K101762 000
10705034034942 K101762 000
10705034034935 K101762 000
10705034034928 K101762 000
10705034034911 K101762 000
10705034034898 K101762 000
10705034034881 K101762 000
10705034034812 K101762 000

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