FDA 510(k)

Bonafix TiBase

K 號：K221673 · 2023-07-14

決定日期2023-07-14

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Bonafix TiBase is the device name listed in this FDA 510(k) record. The listed applicant is Zentek Medical, LLC. It received FDA 510(k) clearance on 2023-07-14 under 510(k) number K221673. 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 Bonafix TiBase?

Bonafix TiBase is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Zentek Medical, LLC. The 510(k) number is K221673.

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

Bonafix TiBase received FDA 510(k) clearance on 2023-07-14, under 510(k) number K221673.

Who is the listed applicant for Bonafix TiBase?

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

What is the FDA product code for Bonafix TiBase?

The FDA product code for Bonafix TiBase is NHA.

其他以 Zentek Medical, LLC 為申請人之記錄

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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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