FDA 510(k)

Tactoset® Injectable Bone Substitute

Número K: K231968 · 2023-12-20

Data da decisão2023-12-20

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tactoset® Injectable Bone Substitute is the device name listed in this FDA 510(k) record. The listed applicant is Anika Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K231968. 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 Tactoset® Injectable Bone Substitute?

Tactoset® Injectable Bone Substitute is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Anika Therapeutics, Inc.. The 510(k) number is K231968.

When did Tactoset® Injectable Bone Substitute receive FDA 510(k) clearance?

Tactoset® Injectable Bone Substitute received FDA 510(k) clearance on 2023-12-20, under 510(k) number K231968.

Who is the listed applicant for Tactoset® Injectable Bone Substitute?

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

What is the FDA product code for Tactoset® Injectable Bone Substitute?

The FDA product code for Tactoset® Injectable Bone Substitute is MQV.

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Fonte oficial

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