SWIFT PLUS 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 Swift Plus Anterior Cervical Plate System.

Pre-market Notification Details

Device IDK072546
510k NumberK072546
Device Name:SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant DEPUY SPINE,INC 325 PARAMONT DRIVE Raynham,  MA  02767
ContactFrank S Jurczak
CorrespondentFrank S Jurczak
DEPUY SPINE,INC 325 PARAMONT DRIVE Raynham,  MA  02767
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-10
Decision Date2007-10-05
Summary:summary

NIH GUDID Devices

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