FDA 510(k)

XN Knee Prosthesis System

Número K: K232175 · 2024-04-14

RequerenteBeijing Chunlizhengda Medical Instruments Co., Ltd.

Data da decisão2024-04-14

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

XN Knee Prosthesis System is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Chunlizhengda Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2024-04-14 under 510(k) number K232175. 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 XN Knee Prosthesis System?

XN Knee Prosthesis System is a medical device that received FDA 510(k) clearance on 2024-04-14. The listed applicant is Beijing Chunlizhengda Medical Instruments Co., Ltd.. The 510(k) number is K232175.

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

XN Knee Prosthesis System received FDA 510(k) clearance on 2024-04-14, under 510(k) number K232175.

Who is the listed applicant for XN Knee Prosthesis System?

The FDA 510(k) record lists Beijing Chunlizhengda Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XN Knee Prosthesis System?

The FDA product code for XN Knee Prosthesis System is JWH.

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Fonte oficial

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