FDA 510(k)

Avitus® DragonWing Large Volume Autograft Delivery System

N.º K: K231456 · 2023-07-17

Fecha de decisión2023-07-17

Código de productoFMF

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Avitus® DragonWing Large Volume Autograft Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Avitus Orthopaedics, Inc.. It received FDA 510(k) clearance on 2023-07-17 under 510(k) number K231456. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Avitus® DragonWing Large Volume Autograft Delivery System?

Avitus® DragonWing Large Volume Autograft Delivery System is a medical device that received FDA 510(k) clearance on 2023-07-17. The listed applicant is Avitus Orthopaedics, Inc.. The 510(k) number is K231456.

When did Avitus® DragonWing Large Volume Autograft Delivery System receive FDA 510(k) clearance?

Avitus® DragonWing Large Volume Autograft Delivery System received FDA 510(k) clearance on 2023-07-17, under 510(k) number K231456.

Who is the listed applicant for Avitus® DragonWing Large Volume Autograft Delivery System?

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

What is the FDA product code for Avitus® DragonWing Large Volume Autograft Delivery System?

The FDA product code for Avitus® DragonWing Large Volume Autograft Delivery System is FMF.

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Otros registros que enlistan a Avitus Orthopaedics, Inc. como solicitante

K230492Avitus® Precision Autograft Delivery System K210631Avitus(r) Bone Harvester K170539Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm

Dispositivos relacionados (Código: FMF)

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Fuente oficial

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