FairFix Adjustable Button System

Fastener, Fixation, Nondegradable, Soft Tissue

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Fairfix Adjustable Button System.

Pre-market Notification Details

Device IDK203259
510k NumberK203259
Device Name:FairFix Adjustable Button System
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Medacta International SA Strada Regina Castel San Pietro,  CH Ch-6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-05
Decision Date2021-03-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630345703934 K203259 000
07630345703927 K203259 000

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