FairFix QT Adjustable Button
K-Number: K223795 · 2023-01-17
ApplicantMedacta International S.A.
Decision Date2023-01-17
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
FairFix QT Adjustable Button is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2023-01-17 under approval number K223795. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FairFix QT Adjustable Button?
FairFix QT Adjustable Button is a medical device that received FDA 510(k) clearance on 2023-01-17. It is manufactured by Medacta International S.A.. The 510(k) number is K223795.
When was FairFix QT Adjustable Button approved by the FDA?
FairFix QT Adjustable Button received FDA 510(k) clearance on 2023-01-17, under approval number K223795.
What company makes FairFix QT Adjustable Button?
FairFix QT Adjustable Button is manufactured by Medacta International S.A..
What is the FDA product code for FairFix QT Adjustable Button?
The FDA product code for FairFix QT Adjustable Button is MBI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.