FDA 510(k)

TrueBalance™ Surgical System

Номер K: K220830 · 2022-09-15

Дата решения2022-09-15

Код продуктаONN

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

TrueBalance™ Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is These Three Medical, LLC. It received FDA 510(k) clearance on 2022-09-15 under 510(k) number K220830. The device is classified under product code ONN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the TrueBalance™ Surgical System?

TrueBalance™ Surgical System is a medical device that received FDA 510(k) clearance on 2022-09-15. The listed applicant is These Three Medical, LLC. The 510(k) number is K220830.

When did TrueBalance™ Surgical System receive FDA 510(k) clearance?

TrueBalance™ Surgical System received FDA 510(k) clearance on 2022-09-15, under 510(k) number K220830.

Who is the listed applicant for TrueBalance™ Surgical System?

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

What is the FDA product code for TrueBalance™ Surgical System?

The FDA product code for TrueBalance™ Surgical System is ONN.

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: ONN)

K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.K252524Quadsense (Quadsense and Quadsense Pro)Eventum Orthopaedics, Ltd.K241298QUADSENSEEventum Orthopaedics, Ltd.K242616Lantern® HipOrthalign, Inc.K200587VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for ShoulderOrthosensor, Inc.

Официальный источник

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