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FDA 510(k)

FairFix AM Adjustable Button FairFix PSP Adjustable Button

K-Number: K221389 · 2022-06-08

ApplicantMedacta International S.A.
Decision Date2022-06-08
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FairFix AM Adjustable Button FairFix PSP Adjustable Button is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2022-06-08 under approval number K221389. 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 AM Adjustable Button FairFix PSP Adjustable Button?

FairFix AM Adjustable Button FairFix PSP Adjustable Button is a medical device that received FDA 510(k) clearance on 2022-06-08. It is manufactured by Medacta International S.A.. The 510(k) number is K221389.

When was FairFix AM Adjustable Button FairFix PSP Adjustable Button approved by the FDA?

FairFix AM Adjustable Button FairFix PSP Adjustable Button received FDA 510(k) clearance on 2022-06-08, under approval number K221389.

What company makes FairFix AM Adjustable Button FairFix PSP Adjustable Button?

FairFix AM Adjustable Button FairFix PSP Adjustable Button is manufactured by Medacta International S.A..

What is the FDA product code for FairFix AM Adjustable Button FairFix PSP Adjustable Button?

The FDA product code for FairFix AM Adjustable Button FairFix PSP 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.

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