FDA 510(k)

BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System

Número K: K252191 · 2025-12-17

Data da decisão2025-12-17

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System is the device name listed in this FDA 510(k) record. The listed applicant is Bonebridge AG. It received FDA 510(k) clearance on 2025-12-17 under 510(k) number K252191. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System?

BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System is a medical device that received FDA 510(k) clearance on 2025-12-17. The listed applicant is Bonebridge AG. The 510(k) number is K252191.

When did BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System receive FDA 510(k) clearance?

BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System received FDA 510(k) clearance on 2025-12-17, under 510(k) number K252191.

Who is the listed applicant for BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System?

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

What is the FDA product code for BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System?

The FDA product code for BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System is HRS.

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