FDA 510(k)

TruAbutment DS; TruBase

K 號：K241485 · 2024-10-09

決定日期2024-10-09

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

TruAbutment DS; TruBase is the device name listed in this FDA 510(k) record. The listed applicant is Truabutment, Inc.. It received FDA 510(k) clearance on 2024-10-09 under 510(k) number K241485. 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 TruAbutment DS; TruBase?

TruAbutment DS; TruBase is a medical device that received FDA 510(k) clearance on 2024-10-09. The listed applicant is Truabutment, Inc.. The 510(k) number is K241485.

When did TruAbutment DS; TruBase receive FDA 510(k) clearance?

TruAbutment DS; TruBase received FDA 510(k) clearance on 2024-10-09, under 510(k) number K241485.

Who is the listed applicant for TruAbutment DS; TruBase?

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

What is the FDA product code for TruAbutment DS; TruBase?

The FDA product code for TruAbutment DS; TruBase is NHA.

其他以 Truabutment, Inc. 為申請人之記錄

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K243255URIS長期植入體與基座 K230438URIS智慧導管植入系統及義肢 K231874AOT & T-L 套管 K213961TruAbutment DS, TruBase K203649TruAbutment DS, TruBase K202579TruAbutment DS, TruBase

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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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