MITEK FASTIN RC ANCHOR

Fastener, Fixation, Nondegradable, Soft Tissue

MITEK PRODUCTS

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

Pre-market Notification Details

Device IDK983818
510k NumberK983818
Device Name:MITEK FASTIN RC ANCHOR
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant MITEK PRODUCTS 60 GLACIER DR. Westwood,  MA  02090
ContactEdward F Kent
CorrespondentEdward F Kent
MITEK PRODUCTS 60 GLACIER DR. Westwood,  MA  02090
Product CodeMBI  
Subsequent Product CodeGAM
Subsequent Product CodeGAS
Subsequent Product CodeHWC
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-29
Decision Date1998-11-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886705008285 K983818 000

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