FDA 510(k)

SAGI Cervical Cage System

Número K: K253213 · 2026-04-20

RequerenteZheJiang Decans Medical Devices Co., Ltd.

Data da decisão2026-04-20

Código do produtoOVE

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SAGI Cervical 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 2026-04-20 under 510(k) number K253213. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SAGI Cervical Cage System?

SAGI Cervical Cage System is a medical device that received FDA 510(k) clearance on 2026-04-20. The listed applicant is ZheJiang Decans Medical Devices Co., Ltd.. The 510(k) number is K253213.

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

SAGI Cervical Cage System received FDA 510(k) clearance on 2026-04-20, under 510(k) number K253213.

Who is the listed applicant for SAGI Cervical 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 SAGI Cervical Cage System?

The FDA product code for SAGI Cervical Cage System is OVE.

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Fonte oficial

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