QUICKANCHOR 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 Quickanchor Ii.

Pre-market Notification Details

Device IDK931253
510k NumberK931253
Device Name:QUICKANCHOR II
ClassificationStaple, Fixation, Bone
Applicant MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood,  MA  02062
ContactRobert Zoletti
CorrespondentRobert 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 Received1993-03-12
Decision Date1994-06-16

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