FDA 510(k)

Dispositivo de Entrega de Allograft (OFAC-C)

Número K: K233368 · 2024-06-25

Data da decisão2024-06-25

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Allograft Delivery Device (OFAC-C) is the device name listed in this FDA 510(k) record. The listed applicant is Bioventus, LLC. It received FDA 510(k) clearance on 2024-06-25 under 510(k) number K233368. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Allograft Delivery Device (OFAC-C)?

Allograft Delivery Device (OFAC-C) is a medical device that received FDA 510(k) clearance on 2024-06-25. The listed applicant is Bioventus, LLC. The 510(k) number is K233368.

When did Allograft Delivery Device (OFAC-C) receive FDA 510(k) clearance?

Allograft Delivery Device (OFAC-C) received FDA 510(k) clearance on 2024-06-25, under 510(k) number K233368.

Who is the listed applicant for Allograft Delivery Device (OFAC-C)?

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

What is the FDA product code for Allograft Delivery Device (OFAC-C)?

The FDA product code for Allograft Delivery Device (OFAC-C) is FMF.

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Fonte oficial

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