FDA 510(k)

Stabil Orthopaedic Solutions Total Knee System

Номер K: K183225 · 2019-02-15

ЗаявительStabil Orthopaedic Solutions, LLC

Дата решения2019-02-15

Код продуктаJWH

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Stabil Orthopaedic Solutions Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Stabil Orthopaedic Solutions, LLC. It received FDA 510(k) clearance on 2019-02-15 under 510(k) number K183225. 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 Stabil Orthopaedic Solutions Total Knee System?

Stabil Orthopaedic Solutions Total Knee System is a medical device that received FDA 510(k) clearance on 2019-02-15. The listed applicant is Stabil Orthopaedic Solutions, LLC. The 510(k) number is K183225.

When did Stabil Orthopaedic Solutions Total Knee System receive FDA 510(k) clearance?

Stabil Orthopaedic Solutions Total Knee System received FDA 510(k) clearance on 2019-02-15, under 510(k) number K183225.

Who is the listed applicant for Stabil Orthopaedic Solutions Total Knee System?

The FDA 510(k) record lists Stabil Orthopaedic Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stabil Orthopaedic Solutions Total Knee System?

The FDA product code for Stabil Orthopaedic Solutions Total Knee System 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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