Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)— 510(k) K243308

Name: FDA 510(k) clearance K243308
Creator: U.S. Food and Drug Administration
Published: 2024-12-20

Substantially Equivalent

Bonebridge AG

FDA 510(k) clearance K243308 for Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste), Substantially Equivalent on 2024-12-20. Applicant: Bonebridge AG. Device class: 2.

Clearance details

Applicant: Bonebridge AG
Product code: Product code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2024-10-21
Decision date: 2024-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zug, CH

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.