FDA 510(k)

Zeta Cranial Navigation System

Номер K: K230661 · 2023-09-08

Дата решения2023-09-08

Код продуктаHAW

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Zeta Cranial Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Zeta Surgical. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K230661. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Zeta Cranial Navigation System?

Zeta Cranial Navigation System is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Zeta Surgical. The 510(k) number is K230661.

When did Zeta Cranial Navigation System receive FDA 510(k) clearance?

Zeta Cranial Navigation System received FDA 510(k) clearance on 2023-09-08, under 510(k) number K230661.

Who is the listed applicant for Zeta Cranial Navigation System?

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

What is the FDA product code for Zeta Cranial Navigation System?

The FDA product code for Zeta Cranial Navigation System is HAW.

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: HAW)

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions AB K253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

Официальный источник

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