FDA Registration
Active
🇺🇸 United States
RAPHAEL Pedicle Screw System
Reg #: 3009051471
·
FEI: 3009051471
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- CTL Medical Corporation
- Registration Number
- 3009051471
- FEI Number
- 3009051471
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2052 McKenzie Drive, Building 1
- City
- Carrollton
- State
- TX
- ZIP
- 75006
- Country
- US
Regulatory Submissions
- 510(k) Number
- K132365
Owner / Operator
- Firm Name
- CTL Amedica
- Operator Number
- 10050984
- Address
- 2052 McKenzie Drive, Building 1
- City
- Carrollton
- State
- TX
- Postal Code
- 75006
- Country
- US
- Correspondent
- Kayla Chott
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-01-22 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-01-22 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2016-01-22 |
Proprietary Names
RAPHAEL Pedicle Screw System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device