FDA 510(k)

ディオネ PEEK スクリューシステム

K番号: K253130 · 2026-05-27

申請者ZheJiang Decans Medical Devices Co., Ltd.

決定日2026-05-27

製品コードMBI

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定Substantially Equivalent

医療機器の概要

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.

よくある質問

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.

申請者としてZheJiang Decans Medical Devices Co., Ltd.を記載するその他の記録

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