FDA 510(k)

GEO Bone Screw System

Número K: K161904 · 2017-01-18

RequerenteGramercy Extremity Orthopeidics, LLC

Data da decisão2017-01-18

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

GEO Bone Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Gramercy Extremity Orthopeidics, LLC. It received FDA 510(k) clearance on 2017-01-18 under 510(k) number K161904. 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 GEO Bone Screw System?

GEO Bone Screw System is a medical device that received FDA 510(k) clearance on 2017-01-18. The listed applicant is Gramercy Extremity Orthopeidics, LLC. The 510(k) number is K161904.

When did GEO Bone Screw System receive FDA 510(k) clearance?

GEO Bone Screw System received FDA 510(k) clearance on 2017-01-18, under 510(k) number K161904.

Who is the listed applicant for GEO Bone Screw System?

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

What is the FDA product code for GEO Bone Screw System?

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

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