FDA 510(k)

Arthrosurface Bone Screws

Número K: K161539 · 2016-06-30

Data da decisão2016-06-30

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Arthrosurface Bone Screws is the device name listed in this FDA 510(k) record. The listed applicant is Arthrosurface, Inc.. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K161539. 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 Arthrosurface Bone Screws?

Arthrosurface Bone Screws is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is Arthrosurface, Inc.. The 510(k) number is K161539.

When did Arthrosurface Bone Screws receive FDA 510(k) clearance?

Arthrosurface Bone Screws received FDA 510(k) clearance on 2016-06-30, under 510(k) number K161539.

Who is the listed applicant for Arthrosurface Bone Screws?

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

What is the FDA product code for Arthrosurface Bone Screws?

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

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Fonte oficial

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