FDA 510(k)

EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )

Número K: K243609 · 2024-12-18

Data da decisão2024-12-18

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) is the device name listed in this FDA 510(k) record. The listed applicant is Etex Corporation. It received FDA 510(k) clearance on 2024-12-18 under 510(k) number K243609. 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 EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )?

EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) is a medical device that received FDA 510(k) clearance on 2024-12-18. The listed applicant is Etex Corporation. The 510(k) number is K243609.

When did EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) receive FDA 510(k) clearance?

EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) received FDA 510(k) clearance on 2024-12-18, under 510(k) number K243609.

Who is the listed applicant for EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )?

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

What is the FDA product code for EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )?

The FDA product code for EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) is MQV.

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Fonte oficial

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