FDA 510(k)

全球模組化更換系統，模組化更換系統，模組化旋轉軸承膝關節元件

K 號：K241716 · 2024-08-02

申請人Howmedica Osteonics Corp., Dba Stryker Orthopaedics

決定日期2024-08-02

產品代碼JDI

諮詢委員會或

決定相當於

器材摘要

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241716. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component?

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K241716.

When did Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component receive FDA 510(k) clearance?

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241716.

Who is the listed applicant for Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component?

The FDA 510(k) record lists Howmedica Osteonics Corp., Dba Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component?

The FDA product code for Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component is JDI.

其他以 Howmedica Osteonics Corp., Dba Stryker Orthopaedics 為申請人之記錄

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相關器械（代碼：JDI）

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。

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