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FDA 510(k)

LORRAINE 2.5/3.5mm Distal Humerus System

K-Number: K250933 · 2025-06-11

ApplicantBonebridge AG
Decision Date2025-06-11
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LORRAINE 2.5/3.5mm Distal Humerus System is a medical device manufactured by Bonebridge AG. It received FDA 510(k) clearance on 2025-06-11 under approval number K250933. 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 LORRAINE 2.5/3.5mm Distal Humerus System?

LORRAINE 2.5/3.5mm Distal Humerus System is a medical device that received FDA 510(k) clearance on 2025-06-11. It is manufactured by Bonebridge AG. The 510(k) number is K250933.

When was LORRAINE 2.5/3.5mm Distal Humerus System approved by the FDA?

LORRAINE 2.5/3.5mm Distal Humerus System received FDA 510(k) clearance on 2025-06-11, under approval number K250933.

What company makes LORRAINE 2.5/3.5mm Distal Humerus System?

LORRAINE 2.5/3.5mm Distal Humerus System is manufactured by Bonebridge AG.

What is the FDA product code for LORRAINE 2.5/3.5mm Distal Humerus System?

The FDA product code for LORRAINE 2.5/3.5mm Distal 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

View all 9 devices →

Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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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