FDA 510(k)

Kinos Axiom Total Ankle System

Номер K: K192778 · 2020-06-30

Дата решения2020-06-30

Код продуктаHSN

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Kinos Axiom Total Ankle System is the device name listed in this FDA 510(k) record. The listed applicant is Kinos Medical. It received FDA 510(k) clearance on 2020-06-30 under 510(k) number K192778. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Kinos Axiom Total Ankle System?

Kinos Axiom Total Ankle System is a medical device that received FDA 510(k) clearance on 2020-06-30. The listed applicant is Kinos Medical. The 510(k) number is K192778.

When did Kinos Axiom Total Ankle System receive FDA 510(k) clearance?

Kinos Axiom Total Ankle System received FDA 510(k) clearance on 2020-06-30, under 510(k) number K192778.

Who is the listed applicant for Kinos Axiom Total Ankle System?

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

What is the FDA product code for Kinos Axiom Total Ankle System?

The FDA product code for Kinos Axiom Total Ankle System is HSN.

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: HSN)

K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker)K252454Kinos Total Ankle SystemRestor3D K250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)K250641Система замены коленного сустава APEX 3DParagon 28, Inc.K240475Hintermann Series H2 Total Ankle SystemVilex, LLC K241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)

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