FDA 510(k)

Knee+

Número K: K230789 · 2023-04-21

Data da decisão2023-04-21

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. It received FDA 510(k) clearance on 2023-04-21 under 510(k) number K230789. 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 2023-04-21. The listed applicant is Pixee Medical. The 510(k) number is K230789.

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

Knee+ received FDA 510(k) clearance on 2023-04-21, under 510(k) number K230789.

Who is the listed applicant for Knee+?

The FDA 510(k) record lists Pixee Medical 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.

Outros registros que listam Pixee Medical como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K243975Knee+K233899Knee+K220104Knee+K213922FX SPS K202750Knee+

Dispositivos Relacionados (Código: SBF)

K261854xvision Spine systemAugmedics, Ltd.K253805Knee+Pixee Medical S.A.S.K252847NextAR Hip PlatformMedacta International S.A.K251639xvision Spine systemAugmedics, Ltd.K252054SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.K252530OptiVu™ ShoulderMr Surgical Solutions, LLC

Fonte oficial

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