FDA 510(k)

U-Motion II 骨盆臼系統-擴展線

K 號：K221149 · 2023-01-05

決定日期2023-01-05

產品代碼LZO

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決定相當於

器材摘要

U-Motion II Acetabular System-Extension line is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2023-01-05 under 510(k) number K221149. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the U-Motion II Acetabular System-Extension line?

U-Motion II Acetabular System-Extension line is a medical device that received FDA 510(k) clearance on 2023-01-05. The listed applicant is United Orthopedic Corporation. The 510(k) number is K221149.

When did U-Motion II Acetabular System-Extension line receive FDA 510(k) clearance?

U-Motion II Acetabular System-Extension line received FDA 510(k) clearance on 2023-01-05, under 510(k) number K221149.

Who is the listed applicant for U-Motion II Acetabular System-Extension line?

FDA 510(k) 記錄中將 United Orthopedic Corporation 列為申請人。這並不單獨確立該設備製造商的身份。

What is the FDA product code for U-Motion II Acetabular System-Extension line?

The FDA product code for U-Motion II Acetabular System-Extension line is LZO.

其他以 United Orthopedic Corporation 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。

K253948動力骨盂杯系統 K252725樹突延伸線 (U2 全膝系統—PSA 型式)K252303樹突延伸線 (USTAR II 系統)K243656U2 全膝系統 – PF+ 髌骨；USTAR II 系統 – PF+ 髌骨 K242315解決模組化修復股骨柄 K243466合規樹枝擴展線，#0

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相關器械（代碼：LZO）

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。

K260173M-Vizion 髋關節更換系統擴充版Medacta International S.A.K253948動力骨盂杯系統United Orthopedic Corporation K261009MobileLink 骨盆杯系統 – 40mm ID 插片（各種）Waldemar Link GmbH & Co. KG K260831Z1 髋關節系統Zimmer, Inc.K260182Avenir® Müller 植入物；Avenir Complete™ 髋關節系統Zimmer, Inc.K260037植入式醫療設備包裝系統更新Implantcast GmbH

官方來源

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