FDA Registration
Active
🇰🇷 South Korea
2938-2006S
Reg #: 3008285983
·
FEI: 3008285983
·
Expires 2025
Products
1
Proprietary Names
45
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- L&K BIOMED CO.,LTD.
- Registration Number
- 3008285983
- FEI Number
- 3008285983
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- #101, 201, #202, 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu
- City
- Yongin-SI Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K223474
Owner / Operator
- Firm Name
- L&K BIOMED CO., LTD.
- Operator Number
- 10033804
- Address
- #101, 201, 202, 16-25, Dongbaekjungang-ro,, 16 beon-gil, Giheung-gu
- City
- Youngin-si
- State
- Gyeonggi
- Postal Code
- 17015
- Country
- KR
- Correspondent
- Kihyang Kim
US Agent
- Business Name
- ComplianceAcuity, Inc
- Contact Name
- Kevin Randall
- Address
- 485 Clinton St, #888
- City
- Ridgeway
- State
- CO
- ZIP
- 81432
- Country
- US
- [email protected]
- Phone
- 303 8280844
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2023-01-26 |
Proprietary Names
2938-2006S
2938-1509S
2938-3009S
2432-0815S
2938-2515S
2938-1512S
2938-1212S
2432-2012S
PathLoc-TA Expandable Lumbar Cage System
2938-2512S
2432-1512S
2432-1509S
2432-1506S
2432-3015S
2938-2012S
2432-3006S
2938-1209S
2938-2506S
2938-2509S
2432-0809S
2938-2009S
2432-0812S
2938-1515S
2938-2015S
2938-3006S
2432-2015S
2432-3009S
2432-1212S
2432-3012S
2432-2515S
2432-2009S
2432-1215S
2432-1209S
2938-3015S
2938-0809S
2432-2506S
2432-2006S
2432-1515S
2432-2512S
2938-0812S
2938-0815S
2432-2509S
2938-3012S
2938-1215S
2938-1506S
Establishment Types
Manufacture Medical Device