FDA 510(k)

連結內科模擬EVO膝關節系統

K 號：K220628 · 2022-05-03

決定日期2022-05-03

產品代碼KRO

諮詢委員會或

決定相當於

器材摘要

LINK Endo-Model EVO Knee 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 2022-05-03 under 510(k) number K220628. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LINK Endo-Model EVO Knee System?

LINK Endo-Model EVO Knee System is a medical device that received FDA 510(k) clearance on 2022-05-03. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K220628.

When did LINK Endo-Model EVO Knee System receive FDA 510(k) clearance?

LINK Endo-Model EVO Knee System received FDA 510(k) clearance on 2022-05-03, under 510(k) number K220628.

Who is the listed applicant for LINK Endo-Model EVO Knee 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 Endo-Model EVO Knee System?

The FDA product code for LINK Endo-Model EVO Knee System is KRO.

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

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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相關器械（代碼：KRO）

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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