FDA 510(k)

Cannulated Screws

N.º K: K213614 · 2022-08-03

Fecha de decisión2022-08-03

Código de productoHWC

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Cannulated Screws is the device name listed in this FDA 510(k) record. The listed applicant is Maxxion Medical, LLC. It received FDA 510(k) clearance on 2022-08-03 under 510(k) number K213614. 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 Cannulated Screws?

Cannulated Screws is a medical device that received FDA 510(k) clearance on 2022-08-03. The listed applicant is Maxxion Medical, LLC. The 510(k) number is K213614.

When did Cannulated Screws receive FDA 510(k) clearance?

Cannulated Screws received FDA 510(k) clearance on 2022-08-03, under 510(k) number K213614.

Who is the listed applicant for Cannulated Screws?

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

What is the FDA product code for Cannulated Screws?

The FDA product code for Cannulated Screws is HWC. This falls under the Cardiovascular category.

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Fuente oficial

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