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Bonebridge AG

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories1
Latest FDA decision2026-06-26
TypeNumberDevice NameCodeDateActions
510(k) K261351 SALGINA 2.5mm Distal Radius SystemHRS2026-06-26 View
510(k) K260228 POYA 3.5mm Medial Proximal Tibia SystemHRS2026-04-24 View
510(k) K252191 BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemHRS2025-12-17 View
510(k) K250933 LORRAINE 2.5/3.5mm Distal Humerus SystemHRS2025-06-11 View
510(k) K243308 Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)HRS2024-12-20 View
510(k) K242399 Bonebridge Osteosynthesis Plating SystemHRS2024-10-31 View
510(k) K240318 SITTER 3.5mm Versatile SystemHRS2024-08-23 View
510(k) K231292 TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus SystemHRS2023-07-19 View
510(k) K213864 Bonebridge Osteosynthesis Plating SystemHRS2022-09-02 View
510(k) K203002 SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular SystemHRS2021-10-05 View

Related Clinical Trials

NCT07774091Clinical Outcomes After Treatment of Distal Humerus Fractures With the LORRAINE 2.5/3.5 mm Distal Humerus SystemNOT_YET_RECRUITINGNCT04427033The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up StudyCOMPLETEDNCT05615649Expanded Indications in the Pediatric BONEBRIDGE PopulationACTIVE_NOT_RECRUITING
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