FDA 510(k)

Haymaker® Screw System

Número K: K222799 · 2023-01-10

RequerenteOrthocircle Spine D.B.A. OC Medical Devices

Data da decisão2023-01-10

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Haymaker® Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Orthocircle Spine D.B.A. OC Medical Devices. It received FDA 510(k) clearance on 2023-01-10 under 510(k) number K222799. 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 Haymaker® Screw System?

Haymaker® Screw System is a medical device that received FDA 510(k) clearance on 2023-01-10. The listed applicant is Orthocircle Spine D.B.A. OC Medical Devices. The 510(k) number is K222799.

When did Haymaker® Screw System receive FDA 510(k) clearance?

Haymaker® Screw System received FDA 510(k) clearance on 2023-01-10, under 510(k) number K222799.

Who is the listed applicant for Haymaker® Screw System?

The FDA 510(k) record lists Orthocircle Spine D.B.A. OC Medical Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Haymaker® Screw System?

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

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