FDA 510(k)

EcoFit® 短柄無釘 cpTi

K 號：K240834 · 2024-06-03

決定日期2024-06-03

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

EcoFit® short stem cementless cpTi is the device name listed in this FDA 510(k) record. The listed applicant is Implantcast GmbH. It received FDA 510(k) clearance on 2024-06-03 under 510(k) number K240834. 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 EcoFit® short stem cementless cpTi?

EcoFit® short stem cementless cpTi is a medical device that received FDA 510(k) clearance on 2024-06-03. The listed applicant is Implantcast GmbH. The 510(k) number is K240834.

When did EcoFit® short stem cementless cpTi receive FDA 510(k) clearance?

EcoFit® short stem cementless cpTi received FDA 510(k) clearance on 2024-06-03, under 510(k) number K240834.

Who is the listed applicant for EcoFit® short stem cementless cpTi?

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 EcoFit® short stem cementless cpTi?

The FDA product code for EcoFit® short stem cementless cpTi 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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