FDA Registration
Active
🇳🇱 Netherlands
Rebound® Cartilage
Reg #: 3004161950
·
FEI: 3004161950
·
Expires 2025
Products
1
Proprietary Names
75
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OSSUR EUROPE B.V.
- Registration Number
- 3004161950
- FEI Number
- 3004161950
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- De Schakel 70
- City
- Eindhoven Noord-Brabant
- Country
- NL
Owner / Operator
- Firm Name
- OSSUR Americas
- Operator Number
- 9026971
- Address
- 200 Spectrum Center Drive, Suite 700
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
US Agent
- Business Name
- Ossur
- Contact Name
- Katla Axelsdottir
- Address
- 200 Spectrum Center Drive, Suite 700
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 949 3823833
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 1993-01-01 |
Proprietary Names
Rebound® Cartilage
Formfit OA Ease
Neoprene Knee Support with Stabilized Patella
Formfit Knee Immobilizer
Premium Elastic Knee Support
SportSleeve
Rebound® Cartilage Custom
Silicone AMS Wrap
Unloader One X
CTi Mission
Unloader Custom
CTi Custom
Undersleeve Neoprene
AMS Wrap
Formfit Knee Braces
Condyle Pad Kit
Thigh/Calf liner EVA
Neo AMS Wrap for CTi® OTS
Rebound Post Op Knee
Neoprene Hinged Knee Support
Rebound® ACL
Elastic Calf Suspension Strap
FX Patella Stabilizer
Flex
Ski boot attachment
Unloader One® X Custom
Rebound® PCL
Unloader One Custom
AMS Sleeve
Formfit Hinged Knees
Unloader Spirit
CTi3 Impact Guard
Flexion Stop Kit
MX Gear Guards
Formfit Knee MCL
AMS Wrap NEO - CTi® Custom
Formfit Knee Hinged Lateral J
CTi OA
Formfit ROM Knees
Unloader One
Formfit Pro Knee
Non-elastic Thigh Strap
Rebound® PCL Custom
Unloader One Plus
Paradigm Custom
SoftSleeve
Paradigm
Neoprene Knee Sleeve
Rebound® ACL Custom
CTi
Undersleeve
Exoform Knee Immobilizer
Knee shield
Formfit Post-Op Knee
Neoprene Wraparound Hinged Knee Support
C180 Rocket
Suspension Strap Kit
Patella cup
Softsleeve
Formfit Pro Knee OA
Oversleeve Neoprene
MX Kit
Padded Sports Oversleeve
MX Patella Cup
Rebound Knee Immobilizer Universal
CTi 3
Extreme
Lycra Liner
Anti-Migration System (AMS) Wrap EVA
Rebound Knee
Strap and Pad Kit
OA Ease
Formfit Knee Buttress
Extension Stop Kit
CTi3 PCL Strap
Establishment Types
Export Device to the United States But Perform No Other Operation on Device