restor3d Metallic Interference Screw — 510(k) de la FDA K193491

Resumen del dispositivo

restor3d Metallic Interference Screw is the device name listed in this FDA 510(k) record. The listed applicant is Restor3D. It received FDA 510(k) clearance on 2020-03-19 under 510(k) number K193491. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the restor3d Metallic Interference Screw?

restor3d Metallic Interference Screw is a medical device that received FDA 510(k) clearance on 2020-03-19. The listed applicant is Restor3D. The 510(k) number is K193491.

When did restor3d Metallic Interference Screw receive FDA 510(k) clearance?

restor3d Metallic Interference Screw received FDA 510(k) clearance on 2020-03-19, under 510(k) number K193491.

Who is the listed applicant for restor3d Metallic Interference Screw?

The FDA 510(k) record lists Restor3D as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for restor3d Metallic Interference Screw?

The FDA product code for restor3d Metallic Interference Screw is HWC. This falls under the Cardiovascular category.

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Dispositivos relacionados (Código: HWC)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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