FDA Registration
Active
🇺🇸 United States
CREO Stabilization System
Reg #: 3005497913
·
FEI: 3005497913
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- MICRO PRECISION SWISS
- Registration Number
- 3005497913
- FEI Number
- 3005497913
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3233 W Harvard St
- City
- Santa Ana
- State
- CA
- ZIP
- 92704
- Country
- US
Regulatory Submissions
- 510(k) Number
- K124058
Owner / Operator
- Firm Name
- MICRO PRECISION SWISS, LLC
- Operator Number
- 10042007
- Address
- 3233 West Harvard St
- City
- Santa Ana
- State
- CA
- Postal Code
- 92704
- Country
- US
- Correspondent
- Joel Roth
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2019-12-31 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2019-12-31 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2019-12-31 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2019-12-31 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-12-31 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2019-12-31 |
Proprietary Names
CREO Stabilization System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)