MITEK CUFFTACK

Fastener, Fixation, Biodegradable, Soft Tissue

MITEK PRODUCTS

The following data is part of a premarket notification filed by Mitek Products with the FDA for Mitek Cufftack.

Pre-market Notification Details

Device IDK003076
510k NumberK003076
Device Name:MITEK CUFFTACK
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant MITEK PRODUCTS 249 VANDERBILT AVE. Norwood,  MA  02062
ContactChristine Kuntz-nassif
CorrespondentChristine Kuntz-nassif
MITEK PRODUCTS 249 VANDERBILT AVE. Norwood,  MA  02062
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-03
Decision Date2000-10-27

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