QUICKANCHOR, MODIFICATION

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, Modification.

Pre-market Notification Details

Device IDK921873
510k NumberK921873
Device Name:QUICKANCHOR, MODIFICATION
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 Received1992-04-08
Decision Date1992-06-09

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