FDA 510(k)

Uni-FuZe-C Bone Strip

Número K: K221726 · 2023-01-18

RequerenteZavation Medical Products, LLC

Data da decisão2023-01-18

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Uni-FuZe-C Bone Strip is the device name listed in this FDA 510(k) record. The listed applicant is Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2023-01-18 under 510(k) number K221726. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Uni-FuZe-C Bone Strip?

Uni-FuZe-C Bone Strip is a medical device that received FDA 510(k) clearance on 2023-01-18. The listed applicant is Zavation Medical Products, LLC. The 510(k) number is K221726.

When did Uni-FuZe-C Bone Strip receive FDA 510(k) clearance?

Uni-FuZe-C Bone Strip received FDA 510(k) clearance on 2023-01-18, under 510(k) number K221726.

Who is the listed applicant for Uni-FuZe-C Bone Strip?

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

What is the FDA product code for Uni-FuZe-C Bone Strip?

The FDA product code for Uni-FuZe-C Bone Strip is MQV.

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Fonte oficial

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