FDA 510(k)

MyPAO SA 指導

K 號：K242603 · 2025-11-19

決定日期2025-11-19

產品代碼PBF

諮詢委員會或

決定相當於

器材摘要

MyPAO SA guides 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 2025-11-19 under 510(k) number K242603. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MyPAO SA guides?

MyPAO SA guides is a medical device that received FDA 510(k) clearance on 2025-11-19. The listed applicant is Medacta International S.A.. The 510(k) number is K242603.

When did MyPAO SA guides receive FDA 510(k) clearance?

MyPAO SA guides received FDA 510(k) clearance on 2025-11-19, under 510(k) number K242603.

Who is the listed applicant for MyPAO SA guides?

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 MyPAO SA guides?

The FDA product code for MyPAO SA guides is PBF.

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

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相關器械（代碼：PBF）

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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