SNAP-PAK (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 Snap-pak (tm).

Pre-market Notification Details

Device IDK905112
510k NumberK905112
Device Name:SNAP-PAK (TM)
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 Received1990-11-13
Decision Date1991-01-04

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