Medical Device Manufacturer · CH , Zug

Bonebridge AG - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2021

Recent clearances: POYA 3.5mm Medial Proximal Tibia System, BRUSIO Trauma Toolbox System, LORRAINE 2.5/3.5mm Distal Humerus System

10
Total
10
Cleared
0
Denied

FDA 510(k) Regulatory Record - Bonebridge AG Orthopedic ✕

10 devices
1-10 of 10
Cleared Jun 26, 2026
SALGINA 2.5mm Distal Radius System
K261351 · HRS
Orthopedic · 63d
Cleared Apr 24, 2026
POYA 3.5mm Medial Proximal Tibia System
K260228 · HRS
Orthopedic · 88d
Cleared Dec 17, 2025
BRUSIO Trauma Toolbox System
K252191 · HRS
Orthopedic · 156d
Cleared Jun 11, 2025
LORRAINE 2.5/3.5mm Distal Humerus System
K250933 · HRS
Orthopedic · 75d
Cleared Dec 20, 2024
Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System,...
K243308 · HRS
Orthopedic · 60d
Cleared Oct 31, 2024
Bonebridge Osteosynthesis Plating System
K242399 · HRS
Orthopedic · 79d
Cleared Aug 23, 2024
SITTER 3.5mm Versatile System
K240318 · HRS
Orthopedic · 203d
Cleared Jul 19, 2023
TAMINA 3.5mm Proximal Humerus System
K231292 · HRS
Orthopedic · 76d
Cleared Sep 02, 2022
Bonebridge Osteosynthesis Plating System
K213864 · HRS
Orthopedic · 266d
Cleared Oct 05, 2021
SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle...
K203002 · HRS
Orthopedic · 369d
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