FDA 510(k)

SGM Femoral Nail System

Número K: K230456 · 2023-06-30

RequerenteChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.

Data da decisão2023-06-30

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SGM Femoral Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K230456. 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 SGM Femoral Nail System?

SGM Femoral Nail System is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. The 510(k) number is K230456.

When did SGM Femoral Nail System receive FDA 510(k) clearance?

SGM Femoral Nail System received FDA 510(k) clearance on 2023-06-30, under 510(k) number K230456.

Who is the listed applicant for SGM Femoral Nail System?

The FDA 510(k) record lists Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SGM Femoral Nail System?

The FDA product code for SGM Femoral Nail System is HSB.

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Fonte oficial

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