FDA 510(k)

Cannulated Screws Neoortho

Numéro K : K162874 · 2017-06-27

DemandeurNeoortho Produtos Ortopedicos S/A

Date de décision2017-06-27

Code produitHWC

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : HWC)

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Source officielle

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