FDA 510(k)

Styrker OrthoMap Express Knee System

Номер K: K153240 · 2016-07-07

Дата решения2016-07-07

Код продуктаOLO

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Styrker OrthoMap Express Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporate. It received FDA 510(k) clearance on 2016-07-07 under 510(k) number K153240. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Styrker OrthoMap Express Knee System?

Styrker OrthoMap Express Knee System is a medical device that received FDA 510(k) clearance on 2016-07-07. The listed applicant is Stryker Corporate. The 510(k) number is K153240.

When did Styrker OrthoMap Express Knee System receive FDA 510(k) clearance?

Styrker OrthoMap Express Knee System received FDA 510(k) clearance on 2016-07-07, under 510(k) number K153240.

Who is the listed applicant for Styrker OrthoMap Express Knee System?

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

What is the FDA product code for Styrker OrthoMap Express Knee System?

The FDA product code for Styrker OrthoMap Express Knee System is OLO.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: OLO)

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