FDA Registration
Active
🇩🇪 Germany
Artikon.genu-bi-lock System-Knee-Joint Set with locking mechanism, size 16 or size 20
Reg #: 8010401
·
FEI: 5812
·
Expires 2025
Products
1
Proprietary Names
17
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- STREIFENEDER ortho.production gmbH
- Registration Number
- 8010401
- FEI Number
- 5812
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- MOOSFELDSTRASSE 10
- City
- EMMERING Bavaria
- Country
- DE
Owner / Operator
- Firm Name
- Streifeneder ortho.production GmbH
- Operator Number
- 8010401
- Address
- MOOSFELDSTRASSE 10, --
- City
- EMMERING, BAVARIA
- State
- DE-BY
- Postal Code
- 82275
- Country
- DE
US Agent
- Business Name
- Fabtech Systems LLC.
- Contact Name
- Greg Mattson
- Address
- 3304 Hill Avenue
- City
- Everett
- State
- WA
- ZIP
- 98201
- Country
- US
- [email protected]
- Phone
- 425 3499557
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2018-10-19 |
Proprietary Names
Artikon.genu-bi-lock System-Knee-Joint Set with locking mechanism, size 16 or size 20
Artikon.genu System-Knee Joint Set, size 16 or size 20, straight, tapered
Artikon.genu System-Knee-Joint Set, size 16 or size 20
Artikon.genu-bi-lock System-Knee-Joint Set with locking mechanism, size 16 or size 20 straight
Artikon.genu System-Knee Joint Set, size 16 or size 20, tapered
Artikon.junior-Knee Joint Bars, bar width 12 mm, 14 mm or 16 mm
GenuSupport.frontal - Hard Frame Knee Orthosis
Artikon System-Laminating Bar Set, size 16 or size 20
Artikon Thigh Bar, aluminium, syst. 16 or syst. 20, aluminium or stainl. Steel
Artikon System-Side Bar Set, stainless steel, size 16 or size 20
Artikon Lamination Calf Bar, stainless steel, syst. 16 or syst. 20
GenuSupport
Artikon.genu System-Knee Joint Set, size 16 or size 20, straight
Artikon System-Side Bar Set, aluminium, size 16 or size 20
Artikon Release Cable for Artikon.genu-bi-lock System-Knee Joint Set
Knee Brace, straight, Knee Orthosis for immobilisation
Artikon Calf Bar, aluminium, syst. 16 or syst. 20, aluminium or stainl. Steel
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device