FDA 510(k)

Cellent Spinal Systems

Número K: K172826 · 2018-10-10

RequerenteJiangsu Trauhui Medical Instrument Co., Ltd.

Data da decisão2018-10-10

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cellent Spinal Systems is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Trauhui Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2018-10-10 under 510(k) number K172826. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Cellent Spinal Systems?

Cellent Spinal Systems is a medical device that received FDA 510(k) clearance on 2018-10-10. The listed applicant is Jiangsu Trauhui Medical Instrument Co., Ltd.. The 510(k) number is K172826.

When did Cellent Spinal Systems receive FDA 510(k) clearance?

Cellent Spinal Systems received FDA 510(k) clearance on 2018-10-10, under 510(k) number K172826.

Who is the listed applicant for Cellent Spinal Systems?

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

What is the FDA product code for Cellent Spinal Systems?

The FDA product code for Cellent Spinal Systems is NKB.

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Fonte oficial

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