FDA 510(k)

動態TiBase

K 號：K243530 · 2025-05-30

決定日期2025-05-30

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Dynamic TiBase is the device name listed in this FDA 510(k) record. The listed applicant is Talladium España, SL. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K243530. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dynamic TiBase?

Dynamic TiBase is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Talladium España, SL. The 510(k) number is K243530.

When did Dynamic TiBase receive FDA 510(k) clearance?

Dynamic TiBase received FDA 510(k) clearance on 2025-05-30, under 510(k) number K243530.

Who is the listed applicant for Dynamic TiBase?

The FDA 510(k) record lists Talladium España, SL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dynamic TiBase?

The FDA product code for Dynamic TiBase is NHA.

其他以 Talladium España, SL 為申請人之記錄

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K243732多單元DAS系統 K243425導向式DAS外科工具組 K241170動態TiBase；TRI螺釘 K231559多單元DAS系統 K232151動態TiBase K212108動態TiBase

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相關器械（代碼：NHA）

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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官方來源

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