FDA 510(k)

Mpact 縮限內層材

K 號：K241461 · 2025-07-31

決定日期2025-07-31

產品代碼KWZ

諮詢委員會或

決定相當於

器材摘要

Mpact Constrained Liner is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2025-07-31 under 510(k) number K241461. The device is classified under product code KWZ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Mpact Constrained Liner?

Mpact Constrained Liner is a medical device that received FDA 510(k) clearance on 2025-07-31. The listed applicant is Medacta International S.A.. The 510(k) number is K241461.

When did Mpact Constrained Liner receive FDA 510(k) clearance?

Mpact Constrained Liner received FDA 510(k) clearance on 2025-07-31, under 510(k) number K241461.

Who is the listed applicant for Mpact Constrained Liner?

FDA 510(k) 記錄將 Medacta International S.A. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Mpact Constrained Liner?

The FDA product code for Mpact Constrained Liner is KWZ.

其他以 Medacta International S.A. 為申請人之記錄

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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相關器械（代碼：KWZ）

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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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。