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 IDK222169
510k NumberK222169
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-21
Decision Date2022-08-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630345797032 K222169 000
07630345797025 K222169 000
07630345797018 K222169 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.