FDA 510(k)

世界線材

K 號：K243162 · 2024-11-25

決定日期2024-11-25

產品代碼MEH

諮詢委員會或

決定相當於

器材摘要

World Liner is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2024-11-25 under 510(k) number K243162. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the World Liner?

World Liner is a medical device that received FDA 510(k) clearance on 2024-11-25. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K243162.

When did World Liner receive FDA 510(k) clearance?

World Liner received FDA 510(k) clearance on 2024-11-25, under 510(k) number K243162.

Who is the listed applicant for World Liner?

The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for World Liner?

The FDA product code for World Liner is MEH.

其他以 Signature Orthopaedics Pty, Ltd. 為申請人之記錄

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相關器械（代碼：MEH）

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。

K261576象納髋關節置入體Corin, Ltd.K250375Allure骨盆柄和骨髓內插釘Waldemar Link GmbH & Co. KG K251166Mfinity 髋關系統Medacta International S.A.K251052Trivicta® 髋關節柄Ortho Development Corp.K242315解決模組化修復股骨柄United Orthopedic Corporation K243839Alteon® HA Femoral StemsExactech, Inc.

官方來源

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