UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

DEPUY SPINE, INC.

The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Uniplate Anterior Cervical Plate System.

Pre-market Notification Details

Device IDK100070
510k NumberK100070
Device Name:UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
ContactChristopher Rogers
CorrespondentChristopher Rogers
DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-11
Decision Date2010-02-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10705034295213 K100070 000
10705034295190 K100070 000
10705034295145 K100070 000
10705034295206 K100070 000
10705034295183 K100070 000
10705034295176 K100070 000
10705034295169 K100070 000
10705034295152 K100070 000

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