FDA 510(k)

ROSA Knee System with UltraSound Imaging Platform (USIP)

Número K: K252058 · 2026-02-06

Data da decisão2026-02-06

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

ROSA Knee System with UltraSound Imaging Platform (USIP) is the device name listed in this FDA 510(k) record. The listed applicant is Balmoral Medical, LLC. It received FDA 510(k) clearance on 2026-02-06 under 510(k) number K252058. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ROSA Knee System with UltraSound Imaging Platform (USIP)?

ROSA Knee System with UltraSound Imaging Platform (USIP) is a medical device that received FDA 510(k) clearance on 2026-02-06. The listed applicant is Balmoral Medical, LLC. The 510(k) number is K252058.

When did ROSA Knee System with UltraSound Imaging Platform (USIP) receive FDA 510(k) clearance?

ROSA Knee System with UltraSound Imaging Platform (USIP) received FDA 510(k) clearance on 2026-02-06, under 510(k) number K252058.

Who is the listed applicant for ROSA Knee System with UltraSound Imaging Platform (USIP)?

The FDA 510(k) record lists Balmoral Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROSA Knee System with UltraSound Imaging Platform (USIP)?

The FDA product code for ROSA Knee System with UltraSound Imaging Platform (USIP) is OLO.

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