FDA 510(k)

Tyber Medical BioTy® Nanotopography Trauma Screw

N.º K: K161597 · 2016-11-16

Fecha de decisión2016-11-16

Código de productoHWC

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Tyber Medical BioTy® Nanotopography Trauma Screw is the device name listed in this FDA 510(k) record. The listed applicant is Tyber Medical, LLC. It received FDA 510(k) clearance on 2016-11-16 under 510(k) number K161597. 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.

Preguntas frecuentes

What is the Tyber Medical BioTy® Nanotopography Trauma Screw?

Tyber Medical BioTy® Nanotopography Trauma Screw is a medical device that received FDA 510(k) clearance on 2016-11-16. The listed applicant is Tyber Medical, LLC. The 510(k) number is K161597.

When did Tyber Medical BioTy® Nanotopography Trauma Screw receive FDA 510(k) clearance?

Tyber Medical BioTy® Nanotopography Trauma Screw received FDA 510(k) clearance on 2016-11-16, under 510(k) number K161597.

Who is the listed applicant for Tyber Medical BioTy® Nanotopography Trauma Screw?

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

What is the FDA product code for Tyber Medical BioTy® Nanotopography Trauma Screw?

The FDA product code for Tyber Medical BioTy® Nanotopography Trauma Screw is HWC. This falls under the Cardiovascular category.

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Fuente oficial

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