FDA 510(k)

ZipE Knotless Tissue Repair and Attachment Devices

Номер K: K162429 · 2017-03-13

ЗаявительZiptek, LLC

Дата решения2017-03-13

Код продуктаMAI

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

ZipE Knotless Tissue Repair and Attachment Devices is the device name listed in this FDA 510(k) record. The listed applicant is Ziptek, LLC. It received FDA 510(k) clearance on 2017-03-13 under 510(k) number K162429. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the ZipE Knotless Tissue Repair and Attachment Devices?

ZipE Knotless Tissue Repair and Attachment Devices is a medical device that received FDA 510(k) clearance on 2017-03-13. The listed applicant is Ziptek, LLC. The 510(k) number is K162429.

When did ZipE Knotless Tissue Repair and Attachment Devices receive FDA 510(k) clearance?

ZipE Knotless Tissue Repair and Attachment Devices received FDA 510(k) clearance on 2017-03-13, under 510(k) number K162429.

Who is the listed applicant for ZipE Knotless Tissue Repair and Attachment Devices?

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

What is the FDA product code for ZipE Knotless Tissue Repair and Attachment Devices?

The FDA product code for ZipE Knotless Tissue Repair and Attachment Devices is MAI.

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: MAI)

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Официальный источник

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