FDA Registration
Active
🇺🇸 United States
Polyaxial Screw
Reg #: 2134470
·
FEI: 3002462840
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- LOWELL,INC.
- Registration Number
- 2134470
- FEI Number
- 3002462840
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9425 83RD AVE. N.
- City
- Brooklyn Park
- State
- MN
- ZIP
- 55445
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133221
Owner / Operator
- Firm Name
- Lowell Inc.
- Operator Number
- 9034888
- Address
- 9425 83RD AVE. N., --
- City
- Minneapolis
- State
- MN
- Postal Code
- 55445
- Country
- US
- Correspondent
- Jack - Wieland
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2014-11-06 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2014-11-06 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2014-11-06 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2014-11-06 |
Proprietary Names
Polyaxial Screw
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)