FDA 510(k)

自由無限™ 全膝系統

K 號：K253314 · 2025-10-29

決定日期2025-10-29

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

Freedom Infinia™ Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2025-10-29 under 510(k) number K253314. 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 Freedom Infinia™ Total Knee System?

Freedom Infinia™ Total Knee System is a medical device that received FDA 510(k) clearance on 2025-10-29. The listed applicant is Maxx Orthopedics, Inc.. The 510(k) number is K253314.

When did Freedom Infinia™ Total Knee System receive FDA 510(k) clearance?

Freedom Infinia™ Total Knee System received FDA 510(k) clearance on 2025-10-29, under 510(k) number K253314.

Who is the listed applicant for Freedom Infinia™ Total Knee System?

FDA 510(k) 記錄將 Maxx Orthopedics, Inc. 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 Freedom Infinia™ Total Knee System?

The FDA product code for Freedom Infinia™ Total Knee System is JWH.

其他以 Maxx Orthopedics, Inc. 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。

K261563自由全膝系統（E-Poly 股骨內襯）K261609自由部分膝關節系統 K253171Libertas 縮窄短 (TS) 未固定股骨柄 (Libertas TS 柄)K252777自由骨顯隆起植入物（骨顯隆起針）K253144Freedom® 全膝系統 – Titan PCK 零件 K243634Maxx Libertas雙極股頭 (雙極股)

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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。