FDA Registration
Active
🇰🇷 South Korea
CTL BIOTEC
Reg #: 3025602479
·
FEI: 3025602479
·
Expires 2026
Products
4
Proprietary Names
9
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- CTL BIOTEC
- Registration Number
- 3025602479
- FEI Number
- 3025602479
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- SEONGSEO-RO 329 SUITE 410, DALSEO-GU
- City
- Daegu
- Country
- KR
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, Lumbar | MAX | Class 2 | Orthopedic | No | 2022-12-13 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2022-12-13 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2024-11-26 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2022-12-13 |
Proprietary Names
VALEO II C
VALEO C (Cervical)
Valeo II LL
VALEO II Interbody Fusion Device
VALEO Spacer System (Lumbar)
KLIMT
NITRO Interbody Fusion Cage System
Valeo® C+CSC with Lumen Interbody Fusion Device
VALEO VBR
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)