FDA 510(k)

Consensus Knee System with TiNbN

Номер K: K241180 · 2025-01-14

Дата решения2025-01-14

Код продуктаJWH

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Consensus Knee System with TiNbN is the device name listed in this FDA 510(k) record. The listed applicant is Shalby Advanced Technologies. It received FDA 510(k) clearance on 2025-01-14 under 510(k) number K241180. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Consensus Knee System with TiNbN?

Consensus Knee System with TiNbN is a medical device that received FDA 510(k) clearance on 2025-01-14. The listed applicant is Shalby Advanced Technologies. The 510(k) number is K241180.

When did Consensus Knee System with TiNbN receive FDA 510(k) clearance?

Consensus Knee System with TiNbN received FDA 510(k) clearance on 2025-01-14, under 510(k) number K241180.

Who is the listed applicant for Consensus Knee System with TiNbN?

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

What is the FDA product code for Consensus Knee System with TiNbN?

The FDA product code for Consensus Knee System with TiNbN is JWH.

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: JWH)

K262057GMK ExtensionMedacta International SA K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Официальный источник

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