FDA 510(k)

Knee+

Número K: K253805 · 2026-04-24

Data da decisão2026-04-24

Código do produtoSBF

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Knee+ is the device name listed in this FDA 510(k) record. The listed applicant is Pixee Medical S.A.S.. It received FDA 510(k) clearance on 2026-04-24 under 510(k) number K253805. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Knee+?

Knee+ is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Pixee Medical S.A.S.. The 510(k) number is K253805.

When did Knee+ receive FDA 510(k) clearance?

Knee+ received FDA 510(k) clearance on 2026-04-24, under 510(k) number K253805.

Who is the listed applicant for Knee+?

The FDA 510(k) record lists Pixee Medical S.A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Knee+?

The FDA product code for Knee+ is SBF.

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Fonte oficial

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