FDA 510(k)

內置逆向全肩關節系統

K 號：K210533 · 2021-08-20

決定日期2021-08-20

產品代碼PHX

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器材摘要

Inset Reverse Total Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Shoulder Innovations, Inc.. It received FDA 510(k) clearance on 2021-08-20 under 510(k) number K210533. 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 Inset Reverse Total Shoulder System?

Inset Reverse Total Shoulder System is a medical device that received FDA 510(k) clearance on 2021-08-20. The listed applicant is Shoulder Innovations, Inc.. The 510(k) number is K210533.

When did Inset Reverse Total Shoulder System receive FDA 510(k) clearance?

Inset Reverse Total Shoulder System received FDA 510(k) clearance on 2021-08-20, under 510(k) number K210533.

Who is the listed applicant for Inset Reverse Total Shoulder System?

FDA 510(k) 記錄將 Shoulder Innovations, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Inset Reverse Total Shoulder System?

The FDA product code for Inset Reverse Total Shoulder System is PHX.

其他以 Shoulder Innovations, Inc. 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。

K262173N22 選擇性肱骨頭 K254128InSet逆向全肩關節系統 K252516N22 輕量球體 K252221內置逆向全肩關節系統 K241817InSet 全肩關節系統 K213615肩部創新全肩系統

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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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