FDA Registration
Active
🇲🇽 Mexico
Formfit Back Support
Reg #: 3008523132
·
FEI: 3008523132
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Ossur Mexico
- Registration Number
- 3008523132
- FEI Number
- 3008523132
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Boulevard Hector Teran Teran 2102, Edificio #1, Col. Canon del Padre
- City
- Tijuana Baja California
- Country
- MX
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 |
|---|---|---|---|---|---|
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 1991-02-12 |
Proprietary Names
Formfit Back Support
Formfit Back Support Air
Formfit Pro Back
Posterior panels without Lateral support
Anterior panel standard & pendulous
OAM Rigid Lumbar
Miami Lumbar Posteo
Posterior panels with Cutout and Lateral support
Posterior panels with Lateral support
Posterior panel Standard
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)