FDA Registration
Active
🇰🇷 South Korea
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System
Reg #: 3008285983
·
FEI: 3008285983
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
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
- K223565
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 |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-02-15 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-02-15 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-02-15 |
Proprietary Names
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System
Establishment Types
Manufacture Medical Device