FairFix AM Adjustable Button FairFix PSP Adjustable Button

Fastener, Fixation, Nondegradable, Soft Tissue

Medacta International S.A.

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

Pre-market Notification Details

Device IDK221389
510k NumberK221389
Device Name:FairFix AM Adjustable Button FairFix PSP Adjustable Button
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Medacta International S.A. Strada Regina Castel San Pietro,  CH CH-6874
ContactStefano Baj
CorrespondentChristopher Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-13
Decision Date2022-06-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630345778703 K221389 000
07630345778697 K221389 000

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