FDA Registration
Active
🇺🇸 United States
CD HORIZON Spinal System, IPC POWEREASE System
Reg #: 3010123256
·
FEI: 3010123256
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- MEDTECH LLC
- Registration Number
- 3010123256
- FEI Number
- 3010123256
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8022 Martha Rd
- City
- Millington
- State
- TN
- ZIP
- 38053
- Country
- US
Regulatory Submissions
- 510(k) Number
- K143019
Owner / Operator
- Firm Name
- MedTech-LLC
- Operator Number
- 10043432
- Address
- 8022 Martha road
- City
- Millington
- State
- TN
- Postal Code
- 38053
- Country
- US
- Correspondent
- Samantha Reed
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2024-05-21 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2024-05-21 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2024-05-21 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2024-05-21 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-05-21 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2024-05-21 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2024-05-21 |
Proprietary Names
CD HORIZON Spinal System, IPC POWEREASE System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)