FDA 510(k)

Устройство для пористой фиксации из титана AmorChem

Номер K: K160791 · 2016-11-15

Дата решения2016-11-15

Код продуктаHWC

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

AmorChem Titanium Porous Fixation Device is the device name listed in this FDA 510(k) record. The listed applicant is Amorchem Holdings, Inc.. It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K160791. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the AmorChem Titanium Porous Fixation Device?

AmorChem Titanium Porous Fixation Device is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Amorchem Holdings, Inc.. The 510(k) number is K160791.

When did AmorChem Titanium Porous Fixation Device receive FDA 510(k) clearance?

AmorChem Titanium Porous Fixation Device received FDA 510(k) clearance on 2016-11-15, under 510(k) number K160791.

Who is the listed applicant for AmorChem Titanium Porous Fixation Device?

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

What is the FDA product code for AmorChem Titanium Porous Fixation Device?

The FDA product code for AmorChem Titanium Porous Fixation Device is HWC. This falls under the Cardiovascular category.

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: HWC)

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps Ortho K261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped K262344Large Compression ScrewsTriMed, Inc.

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