FDA 510(k)

AccuFill Bone Substitute Material

Número K: K190814 · 2019-06-10

Data da decisão2019-06-10

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

AccuFill Bone Substitute Material is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Knee Creations. It received FDA 510(k) clearance on 2019-06-10 under 510(k) number K190814. 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 AccuFill Bone Substitute Material?

AccuFill Bone Substitute Material is a medical device that received FDA 510(k) clearance on 2019-06-10. The listed applicant is Zimmer Knee Creations. The 510(k) number is K190814.

When did AccuFill Bone Substitute Material receive FDA 510(k) clearance?

AccuFill Bone Substitute Material received FDA 510(k) clearance on 2019-06-10, under 510(k) number K190814.

Who is the listed applicant for AccuFill Bone Substitute Material?

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

What is the FDA product code for AccuFill Bone Substitute Material?

The FDA product code for AccuFill Bone Substitute Material is MQV.

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Fonte oficial

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