FDA 510(k)

Parafusos de Osso ALLY™

Número K: K170698 · 2017-05-31

RequerenteProvidence Medical Technology, Inc.

Data da decisão2017-05-31

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ALLY(TM) Bone Screws is the device name listed in this FDA 510(k) record. The listed applicant is Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2017-05-31 under 510(k) number K170698. 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 ALLY(TM) Bone Screws?

ALLY(TM) Bone Screws is a medical device that received FDA 510(k) clearance on 2017-05-31. The listed applicant is Providence Medical Technology, Inc.. The 510(k) number is K170698.

When did ALLY(TM) Bone Screws receive FDA 510(k) clearance?

ALLY(TM) Bone Screws received FDA 510(k) clearance on 2017-05-31, under 510(k) number K170698.

Who is the listed applicant for ALLY(TM) Bone Screws?

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

What is the FDA product code for ALLY(TM) Bone Screws?

The FDA product code for ALLY(TM) Bone Screws is HWC. This falls under the Cardiovascular category.

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Fonte oficial

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