FDA 510(k)

連結 TrabecuLink 髖骨針

K 號：K201364 · 2020-07-17

決定日期2020-07-17

產品代碼MBH

諮詢委員會或

決定相當於

器材摘要

LINK TrabecuLink Femoral Cones 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 2020-07-17 under 510(k) number K201364. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LINK TrabecuLink Femoral Cones?

LINK TrabecuLink Femoral Cones is a medical device that received FDA 510(k) clearance on 2020-07-17. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K201364.

When did LINK TrabecuLink Femoral Cones receive FDA 510(k) clearance?

LINK TrabecuLink Femoral Cones received FDA 510(k) clearance on 2020-07-17, under 510(k) number K201364.

Who is the listed applicant for LINK TrabecuLink Femoral Cones?

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 TrabecuLink Femoral Cones?

The FDA product code for LINK TrabecuLink Femoral Cones is MBH.

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：MBH）

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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