FDA 510(k)

LinkSymphoKnee – 固定潛合超對稱（FB UC）關節表面

K 號：K230471 · 2023-03-21

決定日期2023-03-21

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface is the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2023-03-21 under 510(k) number K230471. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface?

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface is a medical device that received FDA 510(k) clearance on 2023-03-21. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K230471.

When did LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface receive FDA 510(k) clearance?

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface received FDA 510(k) clearance on 2023-03-21, under 510(k) number K230471.

Who is the listed applicant for LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface?

The FDA 510(k) record lists Waldemar Link GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface?

The FDA product code for LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface is JWH.

其他以 Waldemar Link GmbH & Co. KG 為申請人之記錄

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相關器械（代碼：JWH）

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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