FDA 510(k)

Initia Total Hip System & BIOCERAM AZUL(R) HEAD

Номер K: K160895 · 2016-11-01

Дата решения2016-11-01

Код продуктаLZO

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Initia Total Hip System & BIOCERAM AZUL(R) HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Corporation. It received FDA 510(k) clearance on 2016-11-01 under 510(k) number K160895. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Initia Total Hip System & BIOCERAM AZUL(R) HEAD?

Initia Total Hip System & BIOCERAM AZUL(R) HEAD is a medical device that received FDA 510(k) clearance on 2016-11-01. The listed applicant is Kyocera Medical Corporation. The 510(k) number is K160895.

When did Initia Total Hip System & BIOCERAM AZUL(R) HEAD receive FDA 510(k) clearance?

Initia Total Hip System & BIOCERAM AZUL(R) HEAD received FDA 510(k) clearance on 2016-11-01, under 510(k) number K160895.

Who is the listed applicant for Initia Total Hip System & BIOCERAM AZUL(R) HEAD?

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

What is the FDA product code for Initia Total Hip System & BIOCERAM AZUL(R) HEAD?

The FDA product code for Initia Total Hip System & BIOCERAM AZUL(R) HEAD is LZO.

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: LZO)

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG K260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

Официальный источник

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