FDA 510(k)

Freedom® 全膝系統 - 多孔胫骨基板

K 號：K241597 · 2025-02-13

決定日期2025-02-13

產品代碼MBH

諮詢委員會或

決定相當於

器材摘要

Freedom® Total Knee System - Porous Tibial Base Plate 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 2025-02-13 under 510(k) number K241597. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Freedom® Total Knee System - Porous Tibial Base Plate?

Freedom® Total Knee System - Porous Tibial Base Plate is a medical device that received FDA 510(k) clearance on 2025-02-13. The listed applicant is Maxx Orthopedics, Inc.. The 510(k) number is K241597.

When did Freedom® Total Knee System - Porous Tibial Base Plate receive FDA 510(k) clearance?

Freedom® Total Knee System - Porous Tibial Base Plate received FDA 510(k) clearance on 2025-02-13, under 510(k) number K241597.

Who is the listed applicant for Freedom® Total Knee System - Porous Tibial Base Plate?

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® Total Knee System - Porous Tibial Base Plate?

The FDA product code for Freedom® Total Knee System - Porous Tibial Base Plate is MBH.

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）K253314自由無限™ 全膝系統 K253144Freedom® 全膝系統 – Titan PCK 零件

查看所有 19 項裝置 →

相關器械（代碼：MBH）

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。

K261275Unity全膝系統，Unity膝水泥無縫股骨Corin, Ltd.K261462LANDMARK 全膝系統Smith & Nephew, Inc.K253728EVOLUTION® AM BIOFOAM® 道骨系統Microport Orthopedics, Inc.K251840齊默® 佩森娜® 適合個人化膝關節系統Zimmer, Inc.K253189Persona 個人化膝關節系統（Persona 多孔等离子喷涂 PPS 髋骨）Zimmer, Inc.K253328GMK 3D金屬胫骨托延伸器Medacta International S.A.

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。