FDA 510(k)

Catalyst Bone Void Filler

N.º K: K232315 · 2023-09-15

Fecha de decisión2023-09-15

Código de productoMQV

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Catalyst Bone Void Filler is the device name listed in this FDA 510(k) record. The listed applicant is Ossdsign AB. It received FDA 510(k) clearance on 2023-09-15 under 510(k) number K232315. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Catalyst Bone Void Filler?

Catalyst Bone Void Filler is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is Ossdsign AB. The 510(k) number is K232315.

When did Catalyst Bone Void Filler receive FDA 510(k) clearance?

Catalyst Bone Void Filler received FDA 510(k) clearance on 2023-09-15, under 510(k) number K232315.

Who is the listed applicant for Catalyst Bone Void Filler?

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

What is the FDA product code for Catalyst Bone Void Filler?

The FDA product code for Catalyst Bone Void Filler is MQV.

Ensayos clínicos relacionados

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Otros registros que enlistan a Ossdsign AB como solicitante

K212414OSSDSIGN Cranial PSI K190523Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial K181539OSSDSIGN Cranioplug K161090Cranial PSI

Dispositivos relacionados (Código: MQV)

Fuente oficial

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