FDA 510(k)

Medline UNITE® Ankle Fusion Plating System

Número K: K222665 · 2023-01-25

Data da decisão2023-01-25

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medline UNITE® Ankle Fusion Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2023-01-25 under 510(k) number K222665. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Medline UNITE® Ankle Fusion Plating System?

Medline UNITE® Ankle Fusion Plating System is a medical device that received FDA 510(k) clearance on 2023-01-25. The listed applicant is Medline Industries, Inc.. The 510(k) number is K222665.

When did Medline UNITE® Ankle Fusion Plating System receive FDA 510(k) clearance?

Medline UNITE® Ankle Fusion Plating System received FDA 510(k) clearance on 2023-01-25, under 510(k) number K222665.

Who is the listed applicant for Medline UNITE® Ankle Fusion Plating System?

The FDA 510(k) record lists Medline Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline UNITE® Ankle Fusion Plating System?

The FDA product code for Medline UNITE® Ankle Fusion Plating System is HRS.

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Fonte oficial

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