FDA 510(k)

Dunamis Screw and Suture Locking System

Número K: K250867 · 2025-08-15

Data da decisão2025-08-15

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dunamis Screw and Suture Locking System is the device name listed in this FDA 510(k) record. The listed applicant is Dunamis Medical, LLC. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K250867. 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 Dunamis Screw and Suture Locking System?

Dunamis Screw and Suture Locking System is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is Dunamis Medical, LLC. The 510(k) number is K250867.

When did Dunamis Screw and Suture Locking System receive FDA 510(k) clearance?

Dunamis Screw and Suture Locking System received FDA 510(k) clearance on 2025-08-15, under 510(k) number K250867.

Who is the listed applicant for Dunamis Screw and Suture Locking System?

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

What is the FDA product code for Dunamis Screw and Suture Locking System?

The FDA product code for Dunamis Screw and Suture Locking System is HWC. This falls under the Cardiovascular category.

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