FDA 510(k)

側向增強底板

K 號：K210790 · 2021-08-25

決定日期2021-08-25

產品代碼PHX

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決定相當於

器材摘要

Lateralized and Augmented Baseplates is the device name listed in this FDA 510(k) record. The listed applicant is Fx Shoulder USA, Inc.. It received FDA 510(k) clearance on 2021-08-25 under 510(k) number K210790. 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 Lateralized and Augmented Baseplates?

Lateralized and Augmented Baseplates is a medical device that received FDA 510(k) clearance on 2021-08-25. The listed applicant is Fx Shoulder USA, Inc.. The 510(k) number is K210790.

When did Lateralized and Augmented Baseplates receive FDA 510(k) clearance?

Lateralized and Augmented Baseplates received FDA 510(k) clearance on 2021-08-25, under 510(k) number K210790.

Who is the listed applicant for Lateralized and Augmented Baseplates?

The FDA 510(k) record lists Fx Shoulder USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lateralized and Augmented Baseplates?

The FDA product code for Lateralized and Augmented Baseplates is PHX.

其他以 Fx Shoulder USA, Inc. 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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