FDA 510(k)

鐵人三項全膝系統

K 號：K173849 · 2018-02-02

決定日期2018-02-02

產品代碼MBH

諮詢委員會或

決定相當於

器材摘要

Triathlon Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Orthopaedics. It received FDA 510(k) clearance on 2018-02-02 under 510(k) number K173849. 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 Triathlon Total Knee System?

Triathlon Total Knee System is a medical device that received FDA 510(k) clearance on 2018-02-02. The listed applicant is Stryker Orthopaedics. The 510(k) number is K173849.

When did Triathlon Total Knee System receive FDA 510(k) clearance?

Triathlon Total Knee System received FDA 510(k) clearance on 2018-02-02, under 510(k) number K173849.

Who is the listed applicant for Triathlon Total Knee System?

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

What is the FDA product code for Triathlon Total Knee System?

The FDA product code for Triathlon Total Knee System is MBH.

其他以 Stryker Orthopaedics 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：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。

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