FDA 510(k)

LINK MobileLink 骨盆杯系統

K 號：K222066 · 2023-04-14

決定日期2023-04-14

產品代碼LPH

諮詢委員會或

決定相當於

器材摘要

LINK MobileLink Acetabular Cup System 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 2023-04-14 under 510(k) number K222066. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LINK MobileLink Acetabular Cup System?

LINK MobileLink Acetabular Cup System is a medical device that received FDA 510(k) clearance on 2023-04-14. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K222066.

When did LINK MobileLink Acetabular Cup System receive FDA 510(k) clearance?

LINK MobileLink Acetabular Cup System received FDA 510(k) clearance on 2023-04-14, under 510(k) number K222066.

Who is the listed applicant for LINK MobileLink Acetabular Cup System?

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 LINK MobileLink Acetabular Cup System?

The FDA product code for LINK MobileLink Acetabular Cup System is LPH.

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：LPH）

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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