FDA 510(k)

細膠骨膝間隔

K 號：K243024 · 2024-12-20

決定日期2024-12-20

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

Cellbrick Knee Spacer 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 2024-12-20 under 510(k) number K243024. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cellbrick Knee Spacer?

Cellbrick Knee Spacer is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is United Orthopedic Corporation. The 510(k) number is K243024.

When did Cellbrick Knee Spacer receive FDA 510(k) clearance?

Cellbrick Knee Spacer received FDA 510(k) clearance on 2024-12-20, under 510(k) number K243024.

Who is the listed applicant for Cellbrick Knee Spacer?

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 Cellbrick Knee Spacer?

The FDA product code for Cellbrick Knee Spacer is JWH.

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：JWH）

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。

K262057GMK 扩充設備Medacta International SA K260063GSPE 分隔器The General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ 全膝系統Suzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ 全膝系統修復水泥固定胫骨增強器、樹枝擴展和壓入式樹枝擴展B-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK膝關節系統Just Medical Devices (Tianjin) Co., Ltd.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。