FDA 510(k)

Initia Knee System

Número K: K243295 · 2025-01-13

RequerenteKyocera Medical Technologies, Inc.

Data da decisão2025-01-13

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Initia Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2025-01-13 under 510(k) number K243295. 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 Initia Knee System?

Initia Knee System is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K243295.

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

Initia Knee System received FDA 510(k) clearance on 2025-01-13, under 510(k) number K243295.

Who is the listed applicant for Initia Knee System?

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

What is the FDA product code for Initia Knee System?

The FDA product code for Initia Knee System is JWH.

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Outros registros que listam Kyocera Medical Technologies, Inc. como candidato(a)

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Dispositivos Relacionados (Código: JWH)

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Fonte oficial

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