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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 the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2022-08-16 under 510(k) 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. The listed applicant is Medacta International S.A.. The 510(k) number is K222169.

When did FairFix Adjustable Button System receive FDA 510(k) clearance?

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

Who is the listed applicant for FairFix Adjustable Button System?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

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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