FDA Registration
Active
🇺🇸 United States
ST360
Reg #: 2133687
·
FEI: 3000206619
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- UNITY TOOL, INC.
- Registration Number
- 2133687
- FEI Number
- 3000206619
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11660 TROY LN
- City
- Osseo
- State
- MN
- ZIP
- 55369
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133291
Owner / Operator
- Firm Name
- UNITY TOOL, INC.
- Operator Number
- 9025123
- Address
- 11660 TROY LN., --
- City
- Maple Grove
- State
- MN
- Postal Code
- 55369
- Country
- US
- Correspondent
- MICHAEL R VAN ESSEN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2014-12-30 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2014-12-30 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2014-12-30 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2014-12-30 |
Proprietary Names
ST360
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)