BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS

Plate, Fixation, Bone

LAURA CATTABRIGA

The following data is part of a premarket notification filed by Laura Cattabriga with the FDA for Bone Fragment And Fixation Plates, Screws And Washers.

Pre-market Notification Details

Device IDK130614
510k NumberK130614
Device Name:BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS
ClassificationPlate, Fixation, Bone
Applicant LAURA CATTABRIGA 7430 CENTER BAY DRIVE N. Bay Village,  FL  33141
ContactLaura Cattabriga
CorrespondentLaura Cattabriga
LAURA CATTABRIGA 7430 CENTER BAY DRIVE N. Bay Village,  FL  33141
Product CodeHRS  
Subsequent Product CodeHTN
Subsequent Product CodeHWC
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-07
Decision Date2014-01-17
Summary:summary

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