FDA Registration
Active
🇺🇸 United States
ARCH Medical Solutions - Warsaw
Reg #: 3009971621
·
FEI: 3009971621
·
Expires 2025
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- ARCH Medical Solutions - Warsaw
- Registration Number
- 3009971621
- FEI Number
- 3009971621
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2070 N Cessna Rd
- City
- Warsaw
- State
- IN
- ZIP
- 46582
- Country
- US
Regulatory Submissions
- 510(k) Number
- K124058
Owner / Operator
- Firm Name
- Alpha Manufacturing & Design, LLC.
- Operator Number
- 10042381
- Address
- 2070 North Cessna Road
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2016-11-23 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2016-11-23 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-11-23 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2016-11-23 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-11-23 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2016-11-23 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)