CAIS STAPLE

Staple, Fixation, Bone

DEPUY MITEK, A JOHNSON & JOHNSON COMPANY

The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Cais Staple.

Pre-market Notification Details

Device IDK073281
510k NumberK073281
Device Name:CAIS STAPLE
ClassificationStaple, Fixation, Bone
Applicant DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
ContactRuth C Forstadt
CorrespondentRuth C Forstadt
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-21
Decision Date2008-05-02
Summary:summary

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