FDA 510(k)

EZ-TRAX Stryker Mako 全膝關節配上三鐵賽 containment 裝置

K 號：K202270 · 2020-12-02

決定日期2020-12-02

產品代碼KCT

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device is the device name listed in this FDA 510(k) record. The listed applicant is K1 Medical, LLC. It received FDA 510(k) clearance on 2020-12-02 under 510(k) number K202270. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device?

EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device is a medical device that received FDA 510(k) clearance on 2020-12-02. The listed applicant is K1 Medical, LLC. The 510(k) number is K202270.

When did EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device receive FDA 510(k) clearance?

EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device received FDA 510(k) clearance on 2020-12-02, under 510(k) number K202270.

Who is the listed applicant for EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device?

The FDA 510(k) record lists K1 Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device?

The FDA product code for EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device is KCT.

其他以 K1 Medical, LLC 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。

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相關器械（代碼：KCT）

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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官方來源

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