FDA 510(k)

PRO-DENSE LoVisc Bone Graft Substitute

Número K: K200507 · 2020-10-21

Data da decisão2020-10-21

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

PRO-DENSE LoVisc Bone Graft Substitute is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2020-10-21 under 510(k) number K200507. 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 PRO-DENSE LoVisc Bone Graft Substitute?

PRO-DENSE LoVisc Bone Graft Substitute is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K200507.

When did PRO-DENSE LoVisc Bone Graft Substitute receive FDA 510(k) clearance?

PRO-DENSE LoVisc Bone Graft Substitute received FDA 510(k) clearance on 2020-10-21, under 510(k) number K200507.

Who is the listed applicant for PRO-DENSE LoVisc Bone Graft Substitute?

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

What is the FDA product code for PRO-DENSE LoVisc Bone Graft Substitute?

The FDA product code for PRO-DENSE LoVisc Bone Graft Substitute is MQV.

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Fonte oficial

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