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FDA 510(k)

SITTER 3.5mm Versatile System

K-Number: K240318 · 2024-08-23

ApplicantBonebridge AG
Decision Date2024-08-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SITTER 3.5mm Versatile System is a medical device manufactured by Bonebridge AG. It received FDA 510(k) clearance on 2024-08-23 under approval number K240318. 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 SITTER 3.5mm Versatile System?

SITTER 3.5mm Versatile System is a medical device that received FDA 510(k) clearance on 2024-08-23. It is manufactured by Bonebridge AG. The 510(k) number is K240318.

When was SITTER 3.5mm Versatile System approved by the FDA?

SITTER 3.5mm Versatile System received FDA 510(k) clearance on 2024-08-23, under approval number K240318.

What company makes SITTER 3.5mm Versatile System?

SITTER 3.5mm Versatile System is manufactured by Bonebridge AG.

What is the FDA product code for SITTER 3.5mm Versatile System?

The FDA product code for SITTER 3.5mm Versatile System is HRS.

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 K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus 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.

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