FDA Registration
Active
🇰🇷 South Korea
TAEYEON MEDICAL CO., LTD.
Reg #: 3011489618
·
FEI: 3011489618
·
Expires 2026
Products
9
Proprietary Names
5
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- TAEYEON MEDICAL CO., LTD.
- Registration Number
- 3011489618
- FEI Number
- 3011489618
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 132-1 Donghwagongdan-Ro, Munmak-eup
- City
- Wonju-si Gangwon
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K212700
Owner / Operator
- Firm Name
- TAEYEON MEDICAL Co., Ltd.
- Operator Number
- 10089805
- Address
- 132-1 Donghwagongdan-Ro, Munmak-eup
- City
- Wonju-si
- State
- Gangwon
- Postal Code
- 26365
- Country
- KR
- Correspondent
- Gil Woon Choi
US Agent
- Business Name
- LK Consulting Group USA, Inc.
- Contact Name
- Priscilla Chung
- Address
- 2552 Walnut Ave Ste 230
- City
- Tustin
- State
- CA
- ZIP
- 92780
- Country
- US
- [email protected]
- Phone
- 714 9225276
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-01-09 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2024-01-09 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2024-01-09 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2024-01-09 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2024-01-09 |
| Spinal Channeling Instrument, Vertebroplasty | OCJ | Class 1 | Orthopedic | No | 2024-01-09 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2024-01-09 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2024-01-09 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2024-01-09 |
Proprietary Names
Dyflex-II
Balex Bone Expander System
TVP SYSTEM
PCD System
4S Spinal System
Establishment Types
Manufacture Medical Device