FDA Registration
Active
🇰🇷 South Korea
Fixone Meniscal Repair
Reg #: 3025318945
·
FEI: 3025318945
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STERICO Co., Ltd.
- Registration Number
- 3025318945
- FEI Number
- 3025318945
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 173, Wangnim-ro
- City
- Gwangju-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K233601
Owner / Operator
- Firm Name
- STERICO Co., Ltd.
- Operator Number
- 10091816
- Address
- 173, Wangnim-ro
- City
- Gwangju-si
- State
- Gyeonggi
- Postal Code
- 12773
- Country
- KR
US Agent
- Business Name
- Onbix Corp US
- Contact Name
- Uju Krallum
- Address
- 102 N G St Unit 105
- City
- Tacoma
- State
- WA
- ZIP
- 98403
- Country
- US
- [email protected]
- Phone
- 843 5828036
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2025-06-13 |
Proprietary Names
Fixone Meniscal Repair
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)