FDA Registration
Active
🇺🇸 United States
5.5 mm Anti-Rotation Curved Rod
Reg #: 3010120183
·
FEI: 3010120183
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Judson A Smith Company
- Registration Number
- 3010120183
- FEI Number
- 3010120183
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 857 863 Sweinhart and Cleaver Roads
- City
- Boyertown
- State
- PA
- ZIP
- 19512
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133366
Owner / Operator
- Firm Name
- Judson A Smith Company
- Operator Number
- 10043835
- Address
- 857-863 Sweinhart and Cleaver Roads
- City
- Boyertown
- State
- PA
- Postal Code
- 19512
- Country
- US
- Correspondent
- Caryn Mitchell
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2017-04-19 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2017-04-19 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2017-04-19 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2017-04-19 |
Proprietary Names
5.5 mm Anti-Rotation Curved Rod
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)