FDA Registration
Active
🇺🇸 United States
CD HORIZON SPINAL SYSTEM
Reg #: 3009973336
·
FEI: 3009973336
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Engineered Medical Systems, LLC
- Registration Number
- 3009973336
- FEI Number
- 3009973336
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3325 Appling Rd
- City
- Bartlett
- State
- TN
- ZIP
- 38133
- Country
- US
Regulatory Submissions
- 510(k) Number
- K052747
Owner / Operator
- Firm Name
- Engineered Medical Systems, LLC
- Operator Number
- 10042524
- Address
- 3325 Appling Road
- City
- Bartlett
- State
- TN
- Postal Code
- 38133
- Country
- US
- Correspondent
- Dwayne Wisham
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2012-12-05 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2012-12-05 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2012-12-05 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2012-12-05 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2012-12-05 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2012-12-05 |
Proprietary Names
CD HORIZON SPINAL SYSTEM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)