FDA 510(k)

Bfix Orthopedic External Fixator Systems

Número K: K200491 · 2021-01-05

RequerenteAike (Shanghai) Medical Instrument Co., Ltd.

Data da decisão2021-01-05

Código do produtoKTT

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Bfix Orthopedic External Fixator Systems is the device name listed in this FDA 510(k) record. The listed applicant is Aike (Shanghai) Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2021-01-05 under 510(k) number K200491. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Bfix Orthopedic External Fixator Systems?

Bfix Orthopedic External Fixator Systems is a medical device that received FDA 510(k) clearance on 2021-01-05. The listed applicant is Aike (Shanghai) Medical Instrument Co., Ltd.. The 510(k) number is K200491.

When did Bfix Orthopedic External Fixator Systems receive FDA 510(k) clearance?

Bfix Orthopedic External Fixator Systems received FDA 510(k) clearance on 2021-01-05, under 510(k) number K200491.

Who is the listed applicant for Bfix Orthopedic External Fixator Systems?

The FDA 510(k) record lists Aike (Shanghai) Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bfix Orthopedic External Fixator Systems?

The FDA product code for Bfix Orthopedic External Fixator Systems is KTT.

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Fonte oficial

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