FDA 510(k)

GEO Bone Screw System

Número K: K202817 · 2020-10-22

RequerenteGramercy Extremity Orthopedics, LLC

Data da decisão2020-10-22

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 Orthopedics, LLC. It received FDA 510(k) clearance on 2020-10-22 under 510(k) number K202817. 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 2020-10-22. The listed applicant is Gramercy Extremity Orthopedics, LLC. The 510(k) number is K202817.

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

GEO Bone Screw System received FDA 510(k) clearance on 2020-10-22, under 510(k) number K202817.

Who is the listed applicant for GEO Bone Screw System?

The FDA 510(k) record lists Gramercy Extremity Orthopedics, 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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Fonte oficial

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