FDA Registration
Active
🇰🇷 South Korea
AlternatiV+ Max Knotless Anchor (KPN type)
Reg #: 3038284030
·
FEI: 3038284030
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GEUMJEONG ENG
- Registration Number
- 3038284030
- FEI Number
- 3038284030
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11, Samjak-ro 178beon-gil, Ojeong-gu
- City
- Bucheon-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K203523
Owner / Operator
- Firm Name
- Geumjeong ENG
- Operator Number
- 10093322
- Address
- 11, Samjak-ro 178beon-gil, Ojeong-gu
- City
- Bucheon-si
- State
- Gyeonggi
- Postal Code
- 14490
- Country
- KR
- Correspondent
- Jeongyeol Kim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2025-04-29 |
Proprietary Names
AlternatiV+ Max Knotless Anchor (KPN type)
Genesis Knotless Anchor (KPN type)
Fixone Hybrid Anchor (KP,KPN type)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)