FDA Registration
Active
🇺🇸 United States
Prestige Cervical Disc
Reg #: 1835305
·
FEI: 3000203601
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Masterbilt Incorporated
- Registration Number
- 1835305
- FEI Number
- 3000203601
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3801 Voorde Dr
- City
- South Bend
- State
- IN
- ZIP
- 46628
- Country
- US
Regulatory Submissions
- PMA Number
- P060018
Owner / Operator
- Firm Name
- Masterbilt Incorporated
- Operator Number
- 10084599
- Address
- 3801 Voorde Drive
- City
- South Bend
- State
- IN
- Postal Code
- 46628
- Country
- US
- Correspondent
- Rob Michalak
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2022-03-10 |
Proprietary Names
Prestige Cervical Disc
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)