FDA Registration
Active
🇺🇸 United States
Pedicle screw spinal system, adolescent idiopathic scoliosis
Reg #: 2029005
·
FEI: 1000160570
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ARCH Medical Solutions - Escondido LLC
- Registration Number
- 2029005
- FEI Number
- 1000160570
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 950 Borra Place
- City
- ESCONDIDO
- State
- CA
- ZIP
- 92029
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153446
Owner / Operator
- Firm Name
- ARCH Medical Solutions - Escondido LLC
- Operator Number
- 9098779
- Address
- 950 BORRA PLACE, --
- City
- Escondido
- State
- CA
- Postal Code
- 92029
- Country
- US
- Correspondent
- Charles A Green
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-07-08 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-07-08 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2016-07-08 |
Proprietary Names
Pedicle screw spinal system, adolescent idiopathic scoliosis
Establishment Types
Manufacture Medical Device