FDA 510(k)

OrthoSolutions 'System26' Bone Screws

Número K: K163489 · 2017-03-08

Data da decisão2017-03-08

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

OrthoSolutions 'System26' Bone Screws is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Solutions UK Limited. It received FDA 510(k) clearance on 2017-03-08 under 510(k) number K163489. 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 OrthoSolutions 'System26' Bone Screws?

OrthoSolutions 'System26' Bone Screws is a medical device that received FDA 510(k) clearance on 2017-03-08. The listed applicant is Ortho Solutions UK Limited. The 510(k) number is K163489.

When did OrthoSolutions 'System26' Bone Screws receive FDA 510(k) clearance?

OrthoSolutions 'System26' Bone Screws received FDA 510(k) clearance on 2017-03-08, under 510(k) number K163489.

Who is the listed applicant for OrthoSolutions 'System26' Bone Screws?

The FDA 510(k) record lists Ortho Solutions UK Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OrthoSolutions 'System26' Bone Screws?

The FDA product code for OrthoSolutions 'System26' Bone Screws is HWC. This falls under the Cardiovascular category.

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