FDA Registration
Active
🇺🇸 United States
Tegra Medical
Reg #: 3010041499
·
FEI: 3008647423
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Tegra Medical
- Registration Number
- 3010041499
- FEI Number
- 3008647423
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3414 Highway 51 S
- City
- Hernando
- State
- MS
- ZIP
- 38632
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133366
Owner / Operator
- Firm Name
- Tegra Medical
- Operator Number
- 10042736
- Address
- 3414 Highway 51 South
- City
- Hernando
- State
- MS
- Postal Code
- 38632
- Country
- US
- Correspondent
- Deborah Smith
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2021-04-26 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2021-04-26 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2021-04-26 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2021-04-26 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)