FDA Registration
Active
🇰🇷 South Korea
Optimus CMF System - Surgical cutter (various models)
Reg #: 3011530718
·
FEI: 3011530718
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OSTEONIC CO., LTD.
- Registration Number
- 3011530718
- FEI Number
- 3011530718
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 405,505-2,505-3,508,603,902,1004,1005,1103,1201,1202,1203,1204,1205,1206-Ho, 38, Digital-ro 29-gil, Guro-gu, 102, 103-Ho, 24, Digital-ro 27-gil, Guro-gu, 1012, 1013-Ho, 272, Digital-ro, Guro-gu
- City
- Seoul
- Country
- KR
Owner / Operator
- Firm Name
- OSTEONIC Co., Ltd.
- Operator Number
- 10048673
- Address
- 1004Ho,1206Ho,38, Digital-ro 29-gil, Guro-gu, 102Ho, 103Ho, 24, Digital-ro 27-gil, Guro-gu
- City
- Seoul
- State
- KR-NOTA
- Postal Code
- 08381
- Country
- KR
- Correspondent
- Dong Won Lee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2015-03-03 |
Proprietary Names
Optimus CMF System - Surgical cutter (various models)
Optimus Neuro System - Surgical cutter (various models)
IOC-041
IOC-051
IOC-060
IOC-050
IOC-040
Establishment Types
Manufacture Medical Device