FDA 510(k)

ExsoMed ITN Cannulated Screw System

Número K: K171558 · 2017-09-01

Data da decisão2017-09-01

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ExsoMed ITN Cannulated Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Exsomed Holdings Company, LLC. It received FDA 510(k) clearance on 2017-09-01 under 510(k) number K171558. 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.

Perguntas frequentes

What is the ExsoMed ITN Cannulated Screw System?

ExsoMed ITN Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2017-09-01. The listed applicant is Exsomed Holdings Company, LLC. The 510(k) number is K171558.

When did ExsoMed ITN Cannulated Screw System receive FDA 510(k) clearance?

ExsoMed ITN Cannulated Screw System received FDA 510(k) clearance on 2017-09-01, under 510(k) number K171558.

Who is the listed applicant for ExsoMed ITN Cannulated Screw System?

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

What is the FDA product code for ExsoMed ITN Cannulated Screw System?

The FDA product code for ExsoMed ITN Cannulated Screw System is HWC. This falls under the Cardiovascular category.

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