FDA 510(k)

Remedy 髋臼杯

K 號：K173967 · 2018-02-22

決定日期2018-02-22

產品代碼KWL

諮詢委員會或

決定相當於

器材摘要

Remedy Acetabular Cup is the device name listed in this FDA 510(k) record. The listed applicant is Osteoremedies, LLC. It received FDA 510(k) clearance on 2018-02-22 under 510(k) number K173967. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Remedy Acetabular Cup?

Remedy Acetabular Cup is a medical device that received FDA 510(k) clearance on 2018-02-22. The listed applicant is Osteoremedies, LLC. The 510(k) number is K173967.

When did Remedy Acetabular Cup receive FDA 510(k) clearance?

Remedy Acetabular Cup received FDA 510(k) clearance on 2018-02-22, under 510(k) number K173967.

Who is the listed applicant for Remedy Acetabular Cup?

FDA 510(k) 記錄中將 Osteoremedies, LLC 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Remedy Acetabular Cup?

The FDA product code for Remedy Acetabular Cup is KWL.

其他以 Osteoremedies, LLC 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：KWL）

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。

K262290REMEDY POLY+PLUS 快速適合髋白杯Osteoremedies, LLC K260536Prostalac 髋關節系統，SmartSet V+G雙抗生素骨水泥Depuy Ireland UC K253675骨修療股骨間隙系統Osteoremedies, LLC K252326InterSpace GV 髋關節間隔器Tecres S.P.A.K242865Synicem 髋關節間隔器；Synicem 開節間隔器；Synicem 肩關節間隔器Biocomposites, Ltd.K234028COPAL®交換G股間隔器；COPAL®G+VHeraeus Medical GmbH

官方來源

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