FDA 510(k)

Sistema Avançado de Nail Intramedular

Número K: K221221 · 2022-12-21

RequerenteDouble Medical Technology, Inc.

Data da decisão2022-12-21

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Advanced Intramedullary Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K221221. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Advanced Intramedullary Nail System?

Advanced Intramedullary Nail System is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Double Medical Technology, Inc.. The 510(k) number is K221221.

When did Advanced Intramedullary Nail System receive FDA 510(k) clearance?

Advanced Intramedullary Nail System received FDA 510(k) clearance on 2022-12-21, under 510(k) number K221221.

Who is the listed applicant for Advanced Intramedullary Nail System?

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

What is the FDA product code for Advanced Intramedullary Nail System?

The FDA product code for Advanced Intramedullary Nail System is HSB.

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Fonte oficial

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