FDA 510(k)

連結肩部系統 - 反向配置

K 號：K231445 · 2023-11-16

決定日期2023-11-16

產品代碼PHX

諮詢委員會或

決定相當於

器材摘要

LINK Embrace Shoulder System - Reverse 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 2023-11-16 under 510(k) number K231445. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LINK Embrace Shoulder System - Reverse Configuration?

LINK Embrace Shoulder System - Reverse Configuration is a medical device that received FDA 510(k) clearance on 2023-11-16. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K231445.

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

LINK Embrace Shoulder System - Reverse Configuration received FDA 510(k) clearance on 2023-11-16, under 510(k) number K231445.

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

The FDA product code for LINK Embrace Shoulder System - Reverse Configuration is PHX.

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：PHX）

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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