FDA 510(k)

Dione PEEK Screw System

Número K: K253130 · 2026-05-27

RequerenteZheJiang Decans Medical Devices Co., Ltd.

Data da decisão2026-05-27

Código do produtoMBI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dione PEEK Screw 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 2026-05-27 under 510(k) number K253130. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dione PEEK Screw System?

Dione PEEK Screw System is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is ZheJiang Decans Medical Devices Co., Ltd.. The 510(k) number is K253130.

When did Dione PEEK Screw System receive FDA 510(k) clearance?

Dione PEEK Screw System received FDA 510(k) clearance on 2026-05-27, under 510(k) number K253130.

Who is the listed applicant for Dione PEEK Screw 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 Dione PEEK Screw System?

The FDA product code for Dione PEEK Screw System is MBI.

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Fonte oficial

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