FDA 510(k)

Cannulated Screws Neoortho

Número K: K162874 · 2017-06-27

RequerenteNeoortho Produtos Ortopedicos S/A

Data da decisão2017-06-27

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cannulated Screws Neoortho is the device name listed in this FDA 510(k) record. The listed applicant is Neoortho Produtos Ortopedicos S/A. It received FDA 510(k) clearance on 2017-06-27 under 510(k) number K162874. 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 Cannulated Screws Neoortho?

Cannulated Screws Neoortho is a medical device that received FDA 510(k) clearance on 2017-06-27. The listed applicant is Neoortho Produtos Ortopedicos S/A. The 510(k) number is K162874.

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

Cannulated Screws Neoortho received FDA 510(k) clearance on 2017-06-27, under 510(k) number K162874.

Who is the listed applicant for Cannulated Screws Neoortho?

The FDA 510(k) record lists Neoortho Produtos Ortopedicos S/A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cannulated Screws Neoortho?

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

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