FDA Registration
Active
🇰🇷 South Korea
ORTHOTECH CO., LTD.
Reg #: 3042205143
·
FEI: 3042205143
·
Expires 2026
Products
3
Proprietary Names
10
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ORTHOTECH CO., LTD.
- Registration Number
- 3042205143
- FEI Number
- 3042205143
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 100-4, Cheombok-ro
- City
- Dong-Gu Daegu
- Country
- KR
Owner / Operator
- Firm Name
- ORTHOTECH Co., Ltd.
- Operator Number
- 10094495
- Address
- 100-4, Cheombok-ro
- City
- Dong-gu
- State
- Daegu
- Postal Code
- 41061
- Country
- KR
- Correspondent
- Ilhwan Kim
US Agent
- Business Name
- KTR Americas Inc.
- Contact Name
- chuljoo jeon
- Address
- 18000 Studebaker Rd
- City
- Cerritos
- State
- CA
- ZIP
- 90703
- Country
- US
- [email protected]
- Phone
- 562 3172865
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Applicator, Vaginal | HGD | Class 1 | Obstetrics/Gynecology | No | 2025-12-03 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2025-12-03 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2025-12-03 |
Proprietary Names
BA0103.75A
BA0104.75A
BA0102.75A
BA0101.75A
rev.D Carragel S
rev.D Carragel
rev.D Carragel T
Multi-Fix Compact Vacuum Cement Mixing Bowl System - Hip & Knee Joint Type (C-A103)
Multi-Fix Compact Vacuum Cement Mixing Bowl System - Hip & Knee Joint Type (C-A102)
Multi-Fix Compact Vacuum Cement Mixing Bowl System - Hip & Knee Joint Type (C-A100)
Establishment Types
Manufacture Medical Device