FDA 510(k)

SIGNAFUSE Bioactive Bone Graft

Número K: K193513 · 2020-06-18

Data da decisão2020-06-18

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SIGNAFUSE Bioactive Bone Graft is the device name listed in this FDA 510(k) record. The listed applicant is Bioventus. It received FDA 510(k) clearance on 2020-06-18 under 510(k) number K193513. 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 SIGNAFUSE Bioactive Bone Graft?

SIGNAFUSE Bioactive Bone Graft is a medical device that received FDA 510(k) clearance on 2020-06-18. The listed applicant is Bioventus. The 510(k) number is K193513.

When did SIGNAFUSE Bioactive Bone Graft receive FDA 510(k) clearance?

SIGNAFUSE Bioactive Bone Graft received FDA 510(k) clearance on 2020-06-18, under 510(k) number K193513.

Who is the listed applicant for SIGNAFUSE Bioactive Bone Graft?

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

What is the FDA product code for SIGNAFUSE Bioactive Bone Graft?

The FDA product code for SIGNAFUSE Bioactive Bone Graft is MQV.

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Fonte oficial

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