FDA 510(k)

Spinal Inner Fixation System

Número K: K222031 · 2022-10-28

RequerenteChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.

Data da decisão2022-10-28

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Spinal Inner Fixation 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 2022-10-28 under 510(k) number K222031. 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 Spinal Inner Fixation System?

Spinal Inner Fixation System is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. The 510(k) number is K222031.

When did Spinal Inner Fixation System receive FDA 510(k) clearance?

Spinal Inner Fixation System received FDA 510(k) clearance on 2022-10-28, under 510(k) number K222031.

Who is the listed applicant for Spinal Inner Fixation 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 Spinal Inner Fixation System?

The FDA product code for Spinal Inner Fixation System is NKB.

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Fonte oficial

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