FDA 510(k)

Triathlon Total Knee System-Additional Components

Número K: K190402 · 2019-08-22

RequerenteStryker Orthopaedics (Aka Howmedica Osteonics Corp.)

Data da decisão2019-08-22

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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