FDA 510(k)

Syntorr K-wire and Pin System

Номер K: K161489 · 2016-09-16

Дата решения2016-09-16

Код продуктаHTY

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Syntorr K-wire and Pin System is the device name listed in this FDA 510(k) record. The listed applicant is Syntorr, Inc.. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K161489. 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 Syntorr K-wire and Pin System?

Syntorr K-wire and Pin System is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Syntorr, Inc.. The 510(k) number is K161489.

When did Syntorr K-wire and Pin System receive FDA 510(k) clearance?

Syntorr K-wire and Pin System received FDA 510(k) clearance on 2016-09-16, under 510(k) number K161489.

Who is the listed applicant for Syntorr K-wire and Pin System?

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

What is the FDA product code for Syntorr K-wire and Pin System?

The FDA product code for Syntorr K-wire and Pin System 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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