RIGIDFIX BIOCRYL CROSS PIN KITS

Fastener, Fixation, Biodegradable, Soft Tissue

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 Rigidfix Biocryl Cross Pin Kits.

Pre-market Notification Details

Device IDK090669
510k NumberK090669
Device Name:RIGIDFIX BIOCRYL CROSS PIN KITS
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
ContactZheng Liu
CorrespondentZheng Liu
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-13
Decision Date2009-04-03
Summary:summary

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