FDA 510(k)

OvertureTi Knee Resurfacing SystemTM

Número K: K242746 · 2024-10-07

Data da decisão2024-10-07

Código do produtoHSX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

OvertureTi Knee Resurfacing SystemTM is the device name listed in this FDA 510(k) record. The listed applicant is Overture Orthopaedics. It received FDA 510(k) clearance on 2024-10-07 under 510(k) number K242746. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OvertureTi Knee Resurfacing SystemTM?

OvertureTi Knee Resurfacing SystemTM is a medical device that received FDA 510(k) clearance on 2024-10-07. The listed applicant is Overture Orthopaedics. The 510(k) number is K242746.

When did OvertureTi Knee Resurfacing SystemTM receive FDA 510(k) clearance?

OvertureTi Knee Resurfacing SystemTM received FDA 510(k) clearance on 2024-10-07, under 510(k) number K242746.

Who is the listed applicant for OvertureTi Knee Resurfacing SystemTM?

The FDA 510(k) record lists Overture Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OvertureTi Knee Resurfacing SystemTM?

The FDA product code for OvertureTi Knee Resurfacing SystemTM is HSX.

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Fonte oficial

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