FDA Registration
Active
🇺🇸 United States
Simplify® Cervical Artificial Disc
Reg #: 3011461101
·
FEI: 3011461101
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DOT AMERICA, INC.
- Registration Number
- 3011461101
- FEI Number
- 3011461101
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 335 Towerview Dr
- City
- Columbia City
- State
- IN
- ZIP
- 46725
- Country
- US
Regulatory Submissions
- PMA Number
- P200022
Owner / Operator
- Firm Name
- DOT America, Inc.
- Operator Number
- 10048730
- Address
- 335 Towerview Drive
- City
- Columbia City
- State
- IN
- Postal Code
- 46725
- Country
- US
- Correspondent
- Michael Venturini
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2022-04-11 |
Proprietary Names
Simplify® Cervical Artificial Disc
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)