FDA Registration
Active
🇨🇭 Switzerland
BONEBRIDGE AG
Reg #: 3021010222
·
FEI: 3021010222
·
Expires 2026
Products
12
Proprietary Names
33
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- BONEBRIDGE AG
- Registration Number
- 3021010222
- FEI Number
- 3021010222
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Bahnhofstrasse 11
- City
- ZUG
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K250933
Owner / Operator
- Firm Name
- Bonebridge AG
- Operator Number
- 10083420
- Address
- Bahnhofstrasse 11
- City
- ZUG
- State
- CH-ZG
- Postal Code
- 6300
- Country
- CH
- Correspondent
- Michelle Gumpelmayer M.Sc.
US Agent
- Business Name
- confinis USA Inc.
- Contact Name
- Alfred Lerch
- Address
- 600 Park Offices Drive Suite 300, Unit #50
- City
- Durham
- State
- NC
- ZIP
- 27709
- Country
- US
- [email protected]
- Phone
- 910 2289391
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2022-09-21 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2025-06-12 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-06-12 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Template | HWT | Class 1 | Orthopedic | No | 2022-09-21 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2022-09-21 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2022-09-21 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2022-09-21 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2022-09-21 |
Proprietary Names
K-Wires
LORRAINE 2.5/3.5mm Distal Humerus System
Bone Screw LE
POYA 3.5mm Medial Proximal Tibia System
SALTI 2.5/3.5mm Ankle System
POYA 3.5mm Posteromedial Tibia System
TAMINA 3.5mm Proximal Humerus System
BRUSIO Trauma Toolbox System
Power Tool TL Attachments
Trays and racks
POYA 3.5mm Lateral Proximal Tibia System
LORRAINE 3.5mm Distal Humerus System
Trial Implants
POYA 3.5mm Proximal Tibia System
SALGINA 2.5mm Distal Radius System
CASCELLA 3.5mm Superior Clavicle System
LEPORELLO 3.5mm Olecranon System
Cortical Screws ø3.5mm L65mm - L90mm
DALVAZZA 2.5mm Distal Ulna System
Variable Angle Locking Screws ø2.5mm L10mm - L30mm
SALGINA 2.5mm Volar Distal Radius System
Cortical Screws ø2.5mm L10mm - L30mm
Variable Angle Locking Screws ø3.5mm L10mm - L90mm
Clamps
Drill Guides
Aiming Device 3.5mm
Depth Gauges
Cortical Screws ø3.5mm L10mm - L60mm
TRIFT 3.5mm 1/3 Tubular System
Screwdrivers
Bending, contouring instruments
SITTER 3.5mm Versatile System
Drill Bits
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198