MITEK TOGGLE ANCHOR(TM)

Staple, Fixation, Bone

MITEK SURGICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Mitek Toggle Anchor(tm).

Pre-market Notification Details

Device IDK950070
510k NumberK950070
Device Name:MITEK TOGGLE ANCHOR(TM)
ClassificationStaple, Fixation, Bone
Applicant MITEK SURGICAL PRODUCTS, INC. 60 GLACIER DR. Westwood,  MA  02090
ContactEdward F Kent
CorrespondentEdward F Kent
MITEK SURGICAL PRODUCTS, INC. 60 GLACIER DR. Westwood,  MA  02090
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-09
Decision Date1995-05-22

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