FDA Registration
Active
🇰🇷 South Korea
LnK Cervical Interbody Fusion Cage System
Reg #: 3008285983
·
FEI: 3008285983
·
Expires 2025
Products
1
Proprietary Names
219
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
- K151677
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, Cervical | ODP | Class 2 | Orthopedic | No | 2015-07-15 |
Proprietary Names
LnK Cervical Interbody Fusion Cage System
TranS1 Cervical Interbody Fusion Cage System
CastleLoc-C Cervical Interbody Fusion Cage System
5209-1515S
5206-1515
5109-1515S
5106-1217
5205-1517S
5210-1217
5106-1414
5208-1315S
5205-1414S
5108-1417S
5107-1515
5110-1515S
5110-1315
5206-1515S
5109-1517
5208-1515S
5110-1214S
5105-1519
5106-1214S
5207-1515S
5210-1419S
5209-1214S
5205-1214
5207-1517
5205-1517
5106-1417
5107-1517
5207-1517S
5205-1217
5206-1414S
5210-1214S
5205-1519
5108-1315
5205-1315
5208-1515
5206-1217
5207-1214
5205-1417S
5107-1419S
5209-1414S
5208-1517
5105-1519S
5208-1517S
5105-1515
5210-1414
5208-1519S
5110-1519S
5105-1515S
5108-1414S
5107-1417S
5205-1414
5110-1414S
5110-1417
5209-1517
5209-1519
5207-1515
5206-1315
5206-1419
5109-1214
5210-1315S
5107-1315
5208-1519
5109-1417S
5207-1315S
5105-1417
5107-1515S
5110-1315S
5206-1217S
5109-1214S
5109-1419
5105-1414
5108-1414
5209-1217S
5210-1517
5109-1414
5210-1515S
5106-1517
5205-1419S
5210-1414S
5106-1419
5206-1419S
5208-1214
5109-1515
5207-1519
5210-1315
5205-1417
5110-1519
5107-1214S
5107-1519S
5109-1517S
5105-1517
5105-1419S
5207-1217
5209-1517S
5208-1414S
5210-1419
5107-1414S
5210-1519S
5109-1217S
5209-1419
5105-1214S
5106-1515
5207-1417S
5207-1217S
5205-1217S
5109-1414S
5105-1217
5110-1419
5210-1214
5108-1315S
5209-1414
5206-1417
5208-1417
5208-1414
5106-1414S
5110-1517
5208-1419S
5105-1214
5105-1417S
5210-1417S
5108-1214S
5205-1515S
5108-1519S
5109-1419S
5206-1214S
5206-1315S
5106-1519S
5208-1217S
5105-1414S
5209-1419S
5207-1414S
5108-1417
5107-1417
5106-1515S
5107-1519
5206-1417S
5206-1517
5207-1419
5110-1417S
5108-1519
5205-1515
5105-1315
5107-1214
5106-1517S
5206-1517S
5208-1315
5107-1414
5108-1214
5110-1214
5208-1419
5107-1217
5209-1217
5109-1315S
5210-1417
5210-1519
5105-1315S
5109-1519
5110-1419S
5205-1214S
5106-1417S
5205-1419
5206-1214
5210-1517S
5209-1519S
5108-1217
5110-1517S
5108-1517S
5206-1519
5207-1315
5208-1217
5108-1217S
5105-1517S
5209-1515
5106-1217S
5108-1419S
5206-1519S
5108-1515
5107-1419
5209-1315S
5110-1515
5205-1315S
5106-1519
5210-1515
5208-1214S
5107-1517S
5207-1417
5106-1315
5109-1417
5110-1414
5106-1315S
5205-1519S
5109-1519S
5209-1417
5207-1414
5209-1315
5208-1417S
5109-1217
5105-1419
5207-1214S
5106-1419S
5105-1217S
5108-1515S
5107-1217S
5207-1519S
5109-1315
5206-1414
5108-1419
5110-1217S
5110-1217
5207-1419S
5106-1214
5209-1214
5107-1315S
5209-1417S
5210-1217S
5108-1517
Establishment Types
Manufacture Medical Device