MITEK ANCHOR, MITEK ANCHOR II

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 Anchor, Mitek Anchor Ii.

Pre-market Notification Details

Device IDK920213
510k NumberK920213
Device Name:MITEK ANCHOR, MITEK ANCHOR II
ClassificationStaple, Fixation, Bone
Applicant MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood,  MA  02062
ContactRobert P Zoletti
CorrespondentRobert P Zoletti
MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood,  MA  02062
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-16
Decision Date1992-05-01

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