FDA Registration
Active
🇺🇸 United States
GAUTHIER BIOMEDICAL, INC.
Reg #: 2134947
·
FEI: 3010938185
·
Expires 2025
Products
5
Proprietary Names
0
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- GAUTHIER BIOMEDICAL, INC.
- Registration Number
- 2134947
- FEI Number
- 3010938185
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2221 Washington St
- City
- Grafton
- State
- WI
- ZIP
- 53024
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161842
Owner / Operator
- Firm Name
- GAUTHIER BIOMEDICAL, INC.
- Operator Number
- 9041205
- Address
- 2221 Washington Street
- City
- Grafton
- State
- WI
- Postal Code
- 53024
- 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 | 2024-06-11 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2024-06-11 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-06-11 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2024-06-11 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2024-06-11 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)