RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) 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 2.7mm Btb (210815), Femoral 3.3mm St (210816), And Tibial 3.3mm St (210817) Cross Pin Kits.

Pre-market Notification Details

Device IDK091041
510k NumberK091041
Device Name:RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) 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  
Subsequent Product CodeHTY
Subsequent Product CodeHWC
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-13
Decision Date2009-08-07
Summary:summary

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