FDA 510(k)

全邊緣側向及增強基板

K 號：K240278 · 2024-05-15

決定日期2024-05-15

產品代碼PHX

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器材摘要

Full Wedge 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 2024-05-15 under 510(k) number K240278. 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 Full Wedge Lateralized and Augmented Baseplates?

Full Wedge Lateralized and Augmented Baseplates is a medical device that received FDA 510(k) clearance on 2024-05-15. The listed applicant is Fx Shoulder USA, Inc.. The 510(k) number is K240278.

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

Full Wedge Lateralized and Augmented Baseplates received FDA 510(k) clearance on 2024-05-15, under 510(k) number K240278.

Who is the listed applicant for Full Wedge 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 Full Wedge Lateralized and Augmented Baseplates?

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

其他以 Fx Shoulder USA, 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。

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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。

K260556Veritas肩部系統Restor3D K261683Augment 偏心儀器系統Zimmer, Inc.K260102Tornier Perform Reversed Glenoid和Tornier Perform Reversed Augmented Glenoid Shoulder System的設備名稱Stryker Corporation (Tornier, Inc.)K261016MSS - 肱骨反覆蓋擴充件Medacta International, SA K253992Veritas逆向全肩關節系統Restor3D K252404全面反向肩蓋 - HA 髖關節基板Biomet Orthopedics

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