FDA 510(k)

Tyber Medical Trauma Screw

Número K: K252901 · 2025-12-31

Data da decisão2025-12-31

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tyber Medical 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 2025-12-31 under 510(k) number K252901. 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 Tyber Medical Trauma Screw?

Tyber Medical Trauma Screw is a medical device that received FDA 510(k) clearance on 2025-12-31. The listed applicant is Tyber Medical, LLC. The 510(k) number is K252901.

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

Tyber Medical Trauma Screw received FDA 510(k) clearance on 2025-12-31, under 510(k) number K252901.

Who is the listed applicant for Tyber Medical 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 Trauma Screw?

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

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Fonte oficial

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