FDA 510(k)

mXACT 全部義肢外偏中心，mXACT 全部義肢中心，以及 mXACT PRO 全部義肢套件

K 號：K241269 · 2025-01-17

申請人MED-EL Elektromedizinische Geräte GmbH

決定日期2025-01-17

產品代碼ETA

諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。公司名稱：[公司名稱] 產品名稱：[產品名稱]

決定相當於

器材摘要

mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit is the device name listed in this FDA 510(k) record. The listed applicant is MED-EL Elektromedizinische Geräte GmbH. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K241269. The device is classified under product code ETA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit?

mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is MED-EL Elektromedizinische Geräte GmbH. The 510(k) number is K241269.

When did mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit receive FDA 510(k) clearance?

mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit received FDA 510(k) clearance on 2025-01-17, under 510(k) number K241269.

Who is the listed applicant for mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit?

The FDA 510(k) record lists MED-EL Elektromedizinische Geräte GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit?

The FDA product code for mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit is ETA.

其他以 MED-EL Elektromedizinische Geräte GmbH 為申請人之記錄

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相關器械（代碼：ETA）

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。

官方來源

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