FDA 510(k)

狄俄尼索斯PEEK螺釘系統

K 號：K253130 · 2026-05-27

申請人ZheJiang Decans Medical Devices Co., Ltd.

決定日期2026-05-27

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

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.

常見問題

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.

其他以 ZheJiang Decans Medical Devices Co., Ltd. 為申請人之記錄

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相關器械（代碼：MBI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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