FDA 510(k)

Gemini Cervical Fusion Cage System

Número K: K242195 · 2024-11-04

RequerenteZheJiang Decans Medical Devices Co., Ltd.

Data da decisão2024-11-04

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Gemini Cervical Fusion Cage System is the device name listed in this FDA 510(k) record. The listed applicant is ZheJiang Decans Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2024-11-04 under 510(k) number K242195. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Gemini Cervical Fusion Cage System?

Gemini Cervical Fusion Cage System is a medical device that received FDA 510(k) clearance on 2024-11-04. The listed applicant is ZheJiang Decans Medical Devices Co., Ltd.. The 510(k) number is K242195.

When did Gemini Cervical Fusion Cage System receive FDA 510(k) clearance?

Gemini Cervical Fusion Cage System received FDA 510(k) clearance on 2024-11-04, under 510(k) number K242195.

Who is the listed applicant for Gemini Cervical Fusion Cage System?

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

What is the FDA product code for Gemini Cervical Fusion Cage System?

The FDA product code for Gemini Cervical Fusion Cage System is ODP.

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Fonte oficial

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