FDA 510(k)

Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires

Номер K: K213982 · 2022-02-17

Дата решения2022-02-17

Код продуктаHTY

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Instruments. It received FDA 510(k) clearance on 2022-02-17 under 510(k) number K213982. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires?

Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is Pacific Instruments. The 510(k) number is K213982.

When did Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires receive FDA 510(k) clearance?

Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires received FDA 510(k) clearance on 2022-02-17, under 510(k) number K213982.

Who is the listed applicant for Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires?

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

What is the FDA product code for Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires?

The FDA product code for Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires is HTY.

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: HTY)

K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.K253325ZipToe™ Hammertoe Fusion SystemToetal Solutions K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies

Официальный источник

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