FDA Registration
Active
🇺🇸 United States
Valeo C+CSC with Lumen IBFD System
Reg #: 3009051471
·
FEI: 3009051471
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
4
Classifications
1
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
- K173453
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 |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2018-10-23 |
Proprietary Names
Valeo C+CSC with Lumen IBFD System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device