FDA Registration
Active
🇺🇸 United States
FOREFOOT DEFENDER orthotic device
Reg #: 3013428456
·
FEI: 3013428456
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Defender Operations, LLC
- Registration Number
- 3013428456
- FEI Number
- 3013428456
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 5966 south dixie HWY, #300
- City
- South Miami
- State
- FL
- ZIP
- 33143
- Country
- US
Owner / Operator
- Firm Name
- Defender Operations, LLC.
- Operator Number
- 10054153
- Address
- 5966 S. Dixie Hwy
- City
- South Miami
- State
- FL
- Postal Code
- 33143
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2017-02-17 |
Proprietary Names
FOREFOOT DEFENDER orthotic device
DEFENDER INSOLE orthotic device
HEEL DEFENDER orthotic device
DEFENDER EXPANSION SOCK
FOOT DEFENDER protective walking brace for lower extremity
DEFENDER CAST
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198