FDA 510(k)

E-XPE 骨盆组件及 U-Motion II 骨盆杯

K 號：K172833 · 2018-06-12

決定日期2018-06-12

產品代碼OQI

諮詢委員會或

決定相當於

器材摘要

E-XPE Acetabular Components and U-Motion II Acetabular Cup 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 2018-06-12 under 510(k) number K172833. The device is classified under product code OQI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the E-XPE Acetabular Components and U-Motion II Acetabular Cup?

E-XPE Acetabular Components and U-Motion II Acetabular Cup is a medical device that received FDA 510(k) clearance on 2018-06-12. The listed applicant is United Orthopedic Corporation. The 510(k) number is K172833.

When did E-XPE Acetabular Components and U-Motion II Acetabular Cup receive FDA 510(k) clearance?

E-XPE Acetabular Components and U-Motion II Acetabular Cup received FDA 510(k) clearance on 2018-06-12, under 510(k) number K172833.

Who is the listed applicant for E-XPE Acetabular Components and U-Motion II Acetabular Cup?

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 E-XPE Acetabular Components and U-Motion II Acetabular Cup?

The FDA product code for E-XPE Acetabular Components and U-Motion II Acetabular Cup is OQI.

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：OQI）

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。

K252451EPORE® XO 杯系統Implantcast GmbH K192989自由 E-XLPE 模組化外層Maxx Orthopedics, Inc.K173583Exactech® Novation® 及 AcuMatch® E-HXL 骨盆蓋內襯Exactech, Inc.

官方來源

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