樹突延伸線 (U2 全膝系統—PSA 型式)
K 號：K252725 · 2025-09-25
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器材摘要
Stem Extension Line (U2 Total Knee System—PSA Type) 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 2025-09-25 under 510(k) number K252725. 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 Stem Extension Line (U2 Total Knee System—PSA Type)?
Stem Extension Line (U2 Total Knee System—PSA Type) is a medical device that received FDA 510(k) clearance on 2025-09-25. The listed applicant is United Orthopedic Corporation. The 510(k) number is K252725.
When did Stem Extension Line (U2 Total Knee System—PSA Type) receive FDA 510(k) clearance?
Stem Extension Line (U2 Total Knee System—PSA Type) received FDA 510(k) clearance on 2025-09-25, under 510(k) number K252725.
Who is the listed applicant for Stem Extension Line (U2 Total Knee System—PSA Type)?
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 Stem Extension Line (U2 Total Knee System—PSA Type)?
The FDA product code for Stem Extension Line (U2 Total Knee System—PSA Type) is JWH.
相關臨床試驗
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。
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。
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 SAK260063GSPE 分隔器The General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION 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
在 FDA 資料庫中查看 →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。
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