FDA 510(k)

BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System

K-Number: K252191 · 2025-12-17

Decision Date2025-12-17

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Bonebridge AG. The 510(k) number is K252191.

When was BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System approved by the FDA?

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

What company makes BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System?

BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System is manufactured by Bonebridge AG.

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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Other Devices by Bonebridge AG

K203002SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System K213864Bonebridge Osteosynthesis Plating System K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) K242399Bonebridge Osteosynthesis Plating System K240318SITTER 3.5mm Versatile System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.