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 IDK082273
510k NumberK082273
Device Name:UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
ContactFrank Jurczak
CorrespondentFrank Jurczak
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 Received2008-08-11
Decision Date2008-09-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10705034181189 K082273 000
10705034181134 K082273 000
10705034181141 K082273 000
10705034181158 K082273 000
10705034181165 K082273 000
10705034181172 K082273 000
10705034181196 K082273 000
10705034181202 K082273 000
10705034181219 K082273 000
10705034181226 K082273 000
10705034181233 K082273 000
10705034181240 K082273 000
10705034181257 K082273 000
10705034181264 K082273 000
10705034181271 K082273 000
10705034181288 K082273 000
10705034181127 K082273 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.