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
Phone
425 3499557

Products

Device Name Product Code
Joint, Knee, External Brace ITQ

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