FDA Registration
Active
🇰🇷 South Korea
MEDYSSEY CO., LTD.
Reg #: 3007485169
·
FEI: 3007485169
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- MEDYSSEY CO., LTD.
- Registration Number
- 3007485169
- FEI Number
- 3007485169
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 129, Hanbang expo-ro, Jecheon-si, Chungcheogbuk-do
- City
- Jecheon-si Chungbuk
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K142835
Owner / Operator
- Firm Name
- Medyssey Co., Ltd.
- Operator Number
- 10028329
- Address
- 129, Hanbang expo-ro
- City
- Jecheon-City
- State
- Chungbuk
- Postal Code
- 27116
- Country
- KR
US Agent
- Business Name
- Medyssey USA Inc
- Contact Name
- Youngsu Jang
- Address
- 43176 Business Park Dr Ste 107
- City
- Temecula
- State
- CA
- ZIP
- 92590
- Country
- US
- [email protected]
- Phone
- 847 4270200
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2015-06-12 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2015-06-12 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2015-06-12 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2015-06-12 |
Establishment Types
Manufacture Medical Device