FDA Registration
Active
🇰🇷 South Korea
Valeo® C+CSC with Lumen Interbody Fusion Device
Reg #: 3025602479
·
FEI: 3025602479
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CTL BIOTEC
- Registration Number
- 3025602479
- FEI Number
- 3025602479
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- SEONGSEO-RO 329 SUITE 410, DALSEO-GU
- City
- Daegu
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K173453
Owner / Operator
- Firm Name
- CTL Biotec Co., Ltd.
- Operator Number
- 10086812
- Address
- SEONGSEO-RO 329 SUITE 410, DALSEO-GU
- City
- Daegu
- State
- KR-NOTA
- Postal Code
- 42703
- Country
- KR
- Correspondent
- Hyoin Jeon
US Agent
- Business Name
- CTL Medical
- Contact Name
- Kayla Chott
- Address
- 2052 McKenzie Drive, Building 1
- City
- Carrollton
- State
- TX
- ZIP
- 75006
- Country
- US
- [email protected]
- Phone
- 214 5455820
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2022-12-13 |
Proprietary Names
Valeo® C+CSC with Lumen Interbody Fusion Device
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)