FDA 510(k)

鎖定籠，全XPE杯

K 號：K163441 · 2017-08-25

決定日期2017-08-25

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

Locking Cage, Full XPE 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 2017-08-25 under 510(k) number K163441. 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 Locking Cage, Full XPE Cup?

Locking Cage, Full XPE Cup is a medical device that received FDA 510(k) clearance on 2017-08-25. The listed applicant is United Orthopedic Corporation. The 510(k) number is K163441.

When did Locking Cage, Full XPE Cup receive FDA 510(k) clearance?

Locking Cage, Full XPE Cup received FDA 510(k) clearance on 2017-08-25, under 510(k) number K163441.

Who is the listed applicant for Locking Cage, Full XPE 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 Locking Cage, Full XPE Cup?

The FDA product code for Locking Cage, Full XPE Cup 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。

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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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