FDA 510(k)

Actinia® hip stems

K 號：K232371 · 2023-10-19

決定日期2023-10-19

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

Actinia® hip stems is the device name listed in this FDA 510(k) record. The listed applicant is Implantcast GmbH. It received FDA 510(k) clearance on 2023-10-19 under 510(k) number K232371. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Actinia® hip stems?

Actinia® hip stems is a medical device that received FDA 510(k) clearance on 2023-10-19. The listed applicant is Implantcast GmbH. The 510(k) number is K232371.

When did Actinia® hip stems receive FDA 510(k) clearance?

Actinia® hip stems received FDA 510(k) clearance on 2023-10-19, under 510(k) number K232371.

Who is the listed applicant for Actinia® hip stems?

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

What is the FDA product code for Actinia® hip stems?

The FDA product code for Actinia® hip stems is LZO.

其他以 Implantcast GmbH 為申請人之記錄

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相關器械（代碼：LZO）

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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