FDA 510(k)

SK Knee System

Número K: K253961 · 2026-09-01

RequerenteJust Medical Devices (Tianjin) Co., Ltd.

Data da decisão2026-09-01

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SK Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Just Medical Devices (Tianjin) Co., Ltd.. It received FDA 510(k) clearance on 2026-09-01 under 510(k) number K253961. 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 SK Knee System?

SK Knee System is a medical device that received FDA 510(k) clearance on 2026-09-01. The listed applicant is Just Medical Devices (Tianjin) Co., Ltd.. The 510(k) number is K253961.

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

SK Knee System received FDA 510(k) clearance on 2026-09-01, under 510(k) number K253961.

Who is the listed applicant for SK Knee System?

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

What is the FDA product code for SK Knee System?

The FDA product code for SK Knee System is JWH.

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Fonte oficial

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