FDA 510(k)

MotoBAND CP Implant System

Número K: K173710 · 2018-02-12

RequerenteCrossroads Extremity Systems, LLC

Data da decisão2018-02-12

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MotoBAND CP Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Crossroads Extremity Systems, LLC. It received FDA 510(k) clearance on 2018-02-12 under 510(k) number K173710. 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 MotoBAND CP Implant System?

MotoBAND CP Implant System is a medical device that received FDA 510(k) clearance on 2018-02-12. The listed applicant is Crossroads Extremity Systems, LLC. The 510(k) number is K173710.

When did MotoBAND CP Implant System receive FDA 510(k) clearance?

MotoBAND CP Implant System received FDA 510(k) clearance on 2018-02-12, under 510(k) number K173710.

Who is the listed applicant for MotoBAND CP Implant System?

The FDA 510(k) record lists Crossroads Extremity Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MotoBAND CP Implant System?

The FDA product code for MotoBAND CP Implant System is HWC. This falls under the Cardiovascular category.

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Outros registros que listam Crossroads Extremity Systems, LLC como candidato(a)

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Fonte oficial

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