FDA Registration
Active
🇸🇪 Sweden
HII MICRO ROD TO ROD CLAMP 5/3
Reg #: 3003847101
·
FEI: 3003847101
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ELOS MEDTECH TIMMERSDALA AB
- Registration Number
- 3003847101
- FEI Number
- 3003847101
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- BACKEDALSVAGEN
- City
- TIMMERSDALA Vastra Gotaland
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K042019
Owner / Operator
- Firm Name
- ELOS MEDTECH AB
- Operator Number
- 9078344
- Address
- BACKEDALSVAGEN, --
- City
- TIMMERSDALA
- State
- Vastra Gotaland
- Postal Code
- SE-541 71
- Country
- SE
- Correspondent
- Nils - Kristensen
US Agent
- Business Name
- ONYX MEDICAL CORPORATION
- Contact Name
- JODIE GILMORE
- Address
- 1800 North Shelby Oaks Drive
- City
- Memphis
- State
- TN
- ZIP
- 38134
- Country
- US
- [email protected]
- Phone
- 901 3236699
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2013-12-30 |
Proprietary Names
HII MICRO ROD TO ROD CLAMP 5/3
HII MICRO PIN/ROD CLAMP 1.5-2/3
HII MICRO ROD TO ROD CLAMP 3/3
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)