FDA Registration
Active
🇺🇸 United States
ARCH - MEDTORQUE
Reg #: 3005874553
·
FEI: 3005874553
·
Expires 2025
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- ARCH - MEDTORQUE
- Registration Number
- 3005874553
- FEI Number
- 3005874553
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5601 95th Ave
- City
- Kenosha
- State
- WI
- ZIP
- 53144
- Country
- US
Regulatory Submissions
- 510(k) Number
- K124058
Owner / Operator
- Firm Name
- MEDTORQUE, INC.
- Operator Number
- 9069996
- Address
- 5601 95th Avenue, --
- City
- Kenosha
- State
- WI
- Postal Code
- 53144
- Country
- US
- Correspondent
- APRIL E SCHULTZ
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2025-01-23 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-01-23 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-01-23 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-01-23 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-01-23 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-01-23 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)