Data / Medical devices / Switzerland / Bonebridge AG
Bonebridge AG: FDA-registered device maker in Zug, Switzerland, 10 510(k) clearances
Bonebridge AG is registered with the FDA (registration 3021010222) in Zug, Switzerland. It lists 12 device types. The FDA files 10 510(k) clearances under its listings, the newest dated June 26, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3021010222
- Address
- Bahnhofstrasse 11, Zug, Switzerland, 6300
- Owner or operator
- Bonebridge AG (10083420)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 18, 2021
- Registered through
- 2027
- Brand names listed
- Aiming Device 3.5mm, BRUSIO Trauma Toolbox System, Bending, contouring instruments, Bone Screw LE, CASCELLA 3.5mm Superior Clavicle System, Clamps, Cortical Screws ø2.5mm L10mm - L30mm, Cortical Screws ø3.5mm L10mm - L60mm and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Clamp | HXD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 26, 2026 | K261351 | SALGINA 2.5mm Distal Radius System | HRS | Substantially Equivalent | Bonebridge AG | accessdata.fda.gov |
| April 24, 2026 | K260228 | POYA 3.5mm Medial Proximal Tibia System | HRS | Substantially Equivalent | Bonebridge AG | accessdata.fda.gov |
| December 17, 2025 | K252191 | BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System | HRS | Substantially Equivalent | Bonebridge AG | accessdata.fda.gov |
| June 11, 2025 | K250933 | LORRAINE 2.5/3.5mm Distal Humerus System | HRS | Substantially Equivalent | Bonebridge AG | accessdata.fda.gov |
| December 20, 2024 | K243308 | Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) | HRS | Substantially Equivalent | Bonebridge AG | accessdata.fda.gov |
| October 31, 2024 | K242399 | Bonebridge Osteosynthesis Plating System | HRS | Substantially Equivalent | Bonebridge AG | accessdata.fda.gov |
| August 23, 2024 | K240318 | SITTER 3.5mm Versatile System | HRS | Substantially Equivalent | Bonebridge AG | accessdata.fda.gov |
| July 19, 2023 | K231292 | TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System | HRS | Substantially Equivalent | Bonebridge AG | accessdata.fda.gov |
| September 2, 2022 | K213864 | Bonebridge Osteosynthesis Plating System | HRS | Substantially Equivalent | Bonebridge AG | accessdata.fda.gov |
| October 5, 2021 | 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 System | HRS | Substantially Equivalent | Bonebridge AG | accessdata.fda.gov |
Compare with other makers
- All makers of Plate, Fixation, Bone
- All makers of Gauge, Depth
- All makers of Tray, Surgical, Instrument
- All makers of Screw, Fixation, Bone
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Screwdriver
Updated June 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.