FDA 510(k)

ActivaScrew™ Cannulated COM

Número K: K261057 · 2026-09-04

Data da decisão2026-09-04

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ActivaScrew™ Cannulated COM is the device name listed in this FDA 510(k) record. The listed applicant is Bioretec, Ltd.. It received FDA 510(k) clearance on 2026-09-04 under 510(k) number K261057. 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 ActivaScrew™ Cannulated COM?

ActivaScrew™ Cannulated COM is a medical device that received FDA 510(k) clearance on 2026-09-04. The listed applicant is Bioretec, Ltd.. The 510(k) number is K261057.

When did ActivaScrew™ Cannulated COM receive FDA 510(k) clearance?

ActivaScrew™ Cannulated COM received FDA 510(k) clearance on 2026-09-04, under 510(k) number K261057.

Who is the listed applicant for ActivaScrew™ Cannulated COM?

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

What is the FDA product code for ActivaScrew™ Cannulated COM?

The FDA product code for ActivaScrew™ Cannulated COM is HWC. This falls under the Cardiovascular category.

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Fonte oficial

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