FDA 510(k)

MobileLink 骨盆杯系統 – 40mm ID 插片（各種）

K 號：K261009 · 2026-07-06

決定日期2026-07-06

產品代碼LZO

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器材摘要

MobileLink Acetabular Cup System – 40mm ID Inserts (various) 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 2026-07-06 under 510(k) number K261009. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MobileLink Acetabular Cup System – 40mm ID Inserts (various)?

MobileLink Acetabular Cup System – 40mm ID Inserts (various) is a medical device that received FDA 510(k) clearance on 2026-07-06. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K261009.

When did MobileLink Acetabular Cup System – 40mm ID Inserts (various) receive FDA 510(k) clearance?

MobileLink Acetabular Cup System – 40mm ID Inserts (various) received FDA 510(k) clearance on 2026-07-06, under 510(k) number K261009.

Who is the listed applicant for MobileLink Acetabular Cup System – 40mm ID Inserts (various)?

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 MobileLink Acetabular Cup System – 40mm ID Inserts (various)?

The FDA product code for MobileLink Acetabular Cup System – 40mm ID Inserts (various) is LZO.

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：LZO）

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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