FDA Registration
Active
🇰🇷 South Korea
FIX-C 3D Ti ACIF System
Reg #: 3023752918
·
FEI: 3023752918
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INSTITUTE OF ADVANCED CONVERGENCE TECHNOLOGY (IACT)
- Registration Number
- 3023752918
- FEI Number
- 3023752918
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 70 Dongnae-ro, Dong-gu
- City
- Daegu
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K243915
Owner / Operator
- Firm Name
- Institute of Advanced Convergence Technology (IACT)
- Operator Number
- 10085274
- Address
- 70 Dongnae-ro, Dong-gu
- City
- Daegu
- State
- KR-NOTA
- Postal Code
- 41061
- Country
- KR
- Correspondent
- Moon Soo Kim
US Agent
- Business Name
- LK Consulting Group USA, Inc.
- Contact Name
- Priscilla Chung
- Address
- 18881 Von Karman Ave STE 160
- City
- Irvine
- State
- CA
- ZIP
- 92612
- Country
- US
- [email protected]
- Phone
- 714 2025789
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-03-06 |
Proprietary Names
FIX-C 3D Ti ACIF System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)