FDA 510(k)

Locking Plate System

Número K: K162380 · 2017-05-02

RequerenteBeijing Keyi Medical Device Technology Co., Ltd.

Data da decisão2017-05-02

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Locking Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Keyi Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-05-02 under 510(k) number K162380. 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 Locking Plate System?

Locking Plate System is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Beijing Keyi Medical Device Technology Co., Ltd.. The 510(k) number is K162380.

When did Locking Plate System receive FDA 510(k) clearance?

Locking Plate System received FDA 510(k) clearance on 2017-05-02, under 510(k) number K162380.

Who is the listed applicant for Locking Plate System?

The FDA 510(k) record lists Beijing Keyi Medical Device Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Locking Plate System?

The FDA product code for Locking Plate System is HRS.

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Fonte oficial

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