FDA Registration
Active
🇺🇸 United States
Rotium
Reg #: 3014527904
·
FEI: 3014527904
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NANOFIBER SOLUTIONS LLC
- Registration Number
- 3014527904
- FEI Number
- 3014527904
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5164 Blazer Parkway
- City
- Dublin
- State
- OH
- ZIP
- 43017
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201414
Owner / Operator
- Firm Name
- Nanofiber Solutions LLC
- Operator Number
- 10057315
- Address
- 5164 Blazer Parkway
- City
- Dublin
- State
- OH
- Postal Code
- 43017
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2022-10-10 |
Proprietary Names
Rotium
Establishment Types
Manufacture Medical Device