FDA Registration
Active
🇨🇭 Switzerland
Variable Angle Locking Screws ø2.5mm L10mm - L30mm
Reg #: 3021010222
·
FEI: 3021010222
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BONEBRIDGE AG
- Registration Number
- 3021010222
- FEI Number
- 3021010222
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Bahnhofstrasse 11
- City
- ZUG
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K213864
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 |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2022-09-20 |
Proprietary Names
Variable Angle Locking Screws ø2.5mm L10mm - L30mm
CASCELLA 3.5mm Superior Clavicle System
DALVAZZA 2.5mm Distal Ulna System
Cortical Screws ø3.5mm L65mm - L90mm
Variable Angle Locking Screws ø3.5mm L10mm - L90mm
TAMINA 3.5mm Proximal Humerus System
POYA 3.5mm Lateral Proximal Tibia System
POYA 3.5mm Posteromedial Tibia System
LEPORELLO 3.5mm Olecranon System
Cortical Screws ø2.5mm L10mm - L30mm
SALGINA 2.5mm Volar Distal Radius System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility