FDA 510(k)

Dispositivo de Fixação Porosa de Titânio AmorChem

Número K: K160791 · 2016-11-15

Data da decisão2016-11-15

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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