FDA 510(k)

PNK Total Knee System

Número K: K231975 · 2023-11-21

Data da decisão2023-11-21

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

PNK Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Tjc Life Co., Ltd.. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K231975. 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 PNK Total Knee System?

PNK Total Knee System is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Tjc Life Co., Ltd.. The 510(k) number is K231975.

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

PNK Total Knee System received FDA 510(k) clearance on 2023-11-21, under 510(k) number K231975.

Who is the listed applicant for PNK Total Knee System?

The FDA 510(k) record lists Tjc Life Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for PNK Total Knee System is JWH.

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Fonte oficial

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