FDA 510(k)

Tailored-H Cervical Stand Alone System

Номер K: K222903 · 2022-11-18

Дата решения2022-11-18

Код продуктаOVE

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Tailored-H Cervical Stand Alone System is the device name listed in this FDA 510(k) record. The listed applicant is Bespoke Technologies, LLC. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K222903. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Tailored-H Cervical Stand Alone System?

Tailored-H Cervical Stand Alone System is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Bespoke Technologies, LLC. The 510(k) number is K222903.

When did Tailored-H Cervical Stand Alone System receive FDA 510(k) clearance?

Tailored-H Cervical Stand Alone System received FDA 510(k) clearance on 2022-11-18, under 510(k) number K222903.

Who is the listed applicant for Tailored-H Cervical Stand Alone System?

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

What is the FDA product code for Tailored-H Cervical Stand Alone System?

The FDA product code for Tailored-H Cervical Stand Alone System is OVE.

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: OVE)

K263049SABER-C SystemElevation Spine K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution Spine K261279DeltaNEC Interbody SystemNexus Spine K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.

Официальный источник

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