FDA 510(k)

MINIARS SCREWS

N.º K: K143596 · 2016-02-05

Fecha de decisión2016-02-05

Código de productoHWC

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

MINIARS SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Overmed Srl.. It received FDA 510(k) clearance on 2016-02-05 under 510(k) number K143596. 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 MINIARS SCREWS?

MINIARS SCREWS is a medical device that received FDA 510(k) clearance on 2016-02-05. The listed applicant is Overmed Srl.. The 510(k) number is K143596.

When did MINIARS SCREWS receive FDA 510(k) clearance?

MINIARS SCREWS received FDA 510(k) clearance on 2016-02-05, under 510(k) number K143596.

Who is the listed applicant for MINIARS SCREWS?

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

What is the FDA product code for MINIARS SCREWS?

The FDA product code for MINIARS SCREWS is HWC. This falls under the Cardiovascular category.

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Fuente oficial

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