FDA 510(k)

DZ-Tabone Intervertebral Body Fusion Device

Número K: K241073 · 2024-12-06

RequerenteShenzhen Dazhou Medical Technology Co., Ltd.

Data da decisão2024-12-06

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

DZ-Tabone Intervertebral Body Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dazhou Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K241073. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DZ-Tabone Intervertebral Body Fusion Device?

DZ-Tabone Intervertebral Body Fusion Device is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Shenzhen Dazhou Medical Technology Co., Ltd.. The 510(k) number is K241073.

When did DZ-Tabone Intervertebral Body Fusion Device receive FDA 510(k) clearance?

DZ-Tabone Intervertebral Body Fusion Device received FDA 510(k) clearance on 2024-12-06, under 510(k) number K241073.

Who is the listed applicant for DZ-Tabone Intervertebral Body Fusion Device?

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

What is the FDA product code for DZ-Tabone Intervertebral Body Fusion Device?

The FDA product code for DZ-Tabone Intervertebral Body Fusion Device is MAX.

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Fonte oficial

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