FDA 510(k)

Fracture and Correction System

Número K: K180377 · 2018-06-20

Data da decisão2018-06-20

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fracture and Correction System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2018-06-20 under 510(k) number K180377. 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 Fracture and Correction System?

Fracture and Correction System is a medical device that received FDA 510(k) clearance on 2018-06-20. The listed applicant is In2bones USA, LLC. The 510(k) number is K180377.

When did Fracture and Correction System receive FDA 510(k) clearance?

Fracture and Correction System received FDA 510(k) clearance on 2018-06-20, under 510(k) number K180377.

Who is the listed applicant for Fracture and Correction System?

The FDA 510(k) record lists In2bones USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fracture and Correction System?

The FDA product code for Fracture and Correction System is HWC. This falls under the Cardiovascular category.

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Fonte oficial

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