FDA 510(k)

鐵人三項全膝系統-附加零組件

K 號：K190402 · 2019-08-22

申請人Stryker Orthopaedics (Aka Howmedica Osteonics Corp.)

決定日期2019-08-22

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

Triathlon Total Knee System-Additional Components is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Orthopaedics (Aka Howmedica Osteonics Corp.). It received FDA 510(k) clearance on 2019-08-22 under 510(k) number K190402. 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 Triathlon Total Knee System-Additional Components?

Triathlon Total Knee System-Additional Components is a medical device that received FDA 510(k) clearance on 2019-08-22. The listed applicant is Stryker Orthopaedics (Aka Howmedica Osteonics Corp.). The 510(k) number is K190402.

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

Triathlon Total Knee System-Additional Components received FDA 510(k) clearance on 2019-08-22, under 510(k) number K190402.

Who is the listed applicant for Triathlon Total Knee System-Additional Components?

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

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

The FDA product code for Triathlon Total Knee System-Additional Components is JWH.

相關器械（代碼：JWH）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：JWH）

官方來源