FDA 510(k)

IRENE Cannulated Screw System

Número K: K170056 · 2017-10-23

RequerenteTianjin Zhengtian Medical Instrument Co., Ltd.

Data da decisão2017-10-23

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

IRENE Cannulated Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Zhengtian Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2017-10-23 under 510(k) number K170056. 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 IRENE Cannulated Screw System?

IRENE Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2017-10-23. The listed applicant is Tianjin Zhengtian Medical Instrument Co., Ltd.. The 510(k) number is K170056.

When did IRENE Cannulated Screw System receive FDA 510(k) clearance?

IRENE Cannulated Screw System received FDA 510(k) clearance on 2017-10-23, under 510(k) number K170056.

Who is the listed applicant for IRENE Cannulated Screw System?

The FDA 510(k) record lists Tianjin Zhengtian Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRENE Cannulated Screw System?

The FDA product code for IRENE Cannulated Screw System is HWC. This falls under the Cardiovascular category.

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