FDA 510(k)

連結肩部系統-解剖配置

K 號：K210899 · 2021-06-21

決定日期2021-06-21

產品代碼KWT

諮詢委員會或

決定相當於

器材摘要

LINK Embrace Shoulder System- Anatomical Configuration 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 2021-06-21 under 510(k) number K210899. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LINK Embrace Shoulder System- Anatomical Configuration?

LINK Embrace Shoulder System- Anatomical Configuration is a medical device that received FDA 510(k) clearance on 2021-06-21. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K210899.

When did LINK Embrace Shoulder System- Anatomical Configuration receive FDA 510(k) clearance?

LINK Embrace Shoulder System- Anatomical Configuration received FDA 510(k) clearance on 2021-06-21, under 510(k) number K210899.

Who is the listed applicant for LINK Embrace Shoulder System- Anatomical Configuration?

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 Embrace Shoulder System- Anatomical Configuration?

The FDA product code for LINK Embrace Shoulder System- Anatomical Configuration is KWT.

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：KWT）

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。

K262173N22 選擇性肱骨頭Shoulder Innovations, Inc.K250713Equinoxe® 肱骨重建義肢；Equinoxe® 無柄肩關節植入體Exactech, Inc.K251686Tornier 臂骨重建系統 Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO肩部置換系統Implantcast GmbH K241817InSet 全肩關節系統Shoulder Innovations, Inc.K231657AGILON® XO肩部置換系統Implantcast GmbH

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