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FDA 510(k)

FairFix Adjustable Button System

K-Number: K222169 · 2022-08-16

ApplicantMedacta International S.A.
Decision Date2022-08-16
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FairFix Adjustable Button System is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2022-08-16 under approval number K222169. 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 Adjustable Button System?

FairFix Adjustable Button System is a medical device that received FDA 510(k) clearance on 2022-08-16. It is manufactured by Medacta International S.A.. The 510(k) number is K222169.

When was FairFix Adjustable Button System approved by the FDA?

FairFix Adjustable Button System received FDA 510(k) clearance on 2022-08-16, under approval number K222169.

What company makes FairFix Adjustable Button System?

FairFix Adjustable Button System is manufactured by Medacta International S.A..

What is the FDA product code for FairFix Adjustable Button System?

The FDA product code for FairFix Adjustable Button System 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.

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