MITEK 2GII MENISCAL REPAIR SYSTEM

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 2gii Meniscal Repair System.

Pre-market Notification Details

Device IDK002406
510k NumberK002406
Device Name:MITEK 2GII MENISCAL REPAIR SYSTEM
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant MITEK PRODUCTS 249 VANDERBILT AVE. Norwood,  MA  02062
ContactCarol Chaoui
CorrespondentCarol Chaoui
MITEK PRODUCTS 249 VANDERBILT AVE. Norwood,  MA  02062
Product CodeMAI  
Subsequent Product CodeGAM
Subsequent Product CodeGAS
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-07
Decision Date2001-02-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886705010264 K002406 000
10886705010257 K002406 000
10886705010240 K002406 000
10886705010233 K002406 000
10886705010226 K002406 000

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