FDA 510(k)

MedalOne 全膝系統

K 號：K244039 · 2025-02-28

申請人Suzhou Microport Orthorecon Co., Ltd.

決定日期2025-02-28

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

MedalOne Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Microport Orthorecon Co., Ltd.. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K244039. 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 MedalOne Total Knee System?

MedalOne Total Knee System is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is Suzhou Microport Orthorecon Co., Ltd.. The 510(k) number is K244039.

When did MedalOne Total Knee System receive FDA 510(k) clearance?

MedalOne Total Knee System received FDA 510(k) clearance on 2025-02-28, under 510(k) number K244039.

Who is the listed applicant for MedalOne Total Knee System?

FDA 510(k) 記錄將蘇州微Port Orthorecon有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for MedalOne Total Knee System?

The FDA product code for MedalOne Total Knee System is JWH.

其他以 Suzhou Microport Orthorecon Co., Ltd. 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。

K262293EVOLUTION MPX™ 全膝系統

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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