DEPUY ACROMED VBR SYSTEM

Spinal Vertebral Body Replacement Device

DEPUY ACROMED

The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Depuy Acromed Vbr System.

Pre-market Notification Details

Device IDK030833
510k NumberK030833
Device Name:DEPUY ACROMED VBR SYSTEM
ClassificationSpinal Vertebral Body Replacement Device
Applicant DEPUY ACROMED 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
ContactKaren F Jurczak
CorrespondentKaren F Jurczak
DEPUY ACROMED 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-17
Decision Date2003-04-10
Summary:summary

NIH GUDID Devices

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