FDA 510(k)

Spider Frame External Fixation System

Номер K: K170482 · 2017-09-27

ЗаявительTasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S

Дата решения2017-09-27

Код продуктаKTT

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Spider Frame External Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S. It received FDA 510(k) clearance on 2017-09-27 under 510(k) number K170482. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Spider Frame External Fixation System?

Spider Frame External Fixation System is a medical device that received FDA 510(k) clearance on 2017-09-27. The listed applicant is Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S. The 510(k) number is K170482.

When did Spider Frame External Fixation System receive FDA 510(k) clearance?

Spider Frame External Fixation System received FDA 510(k) clearance on 2017-09-27, under 510(k) number K170482.

Who is the listed applicant for Spider Frame External Fixation System?

The FDA 510(k) record lists Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spider Frame External Fixation System?

The FDA product code for Spider Frame External Fixation System is KTT.

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: KTT)

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC K260900DYNEX® External Fixation SystemsVilex, LLC K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean Global K253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

Официальный источник

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