FDA Device Establishments · JSON-LD · Markdown
FEI 3008285983 · Manufacture Medical Device · Status: Active
| FEI Number | 3008285983 |
|---|---|
| Owner / Operator | L&K BIOMED CO., LTD. (#10033804) |
| Address | #101, 201, #202, 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu, Yongin-SI Gyeonggi, 17015, KR |
| Mandatory US Agent | ComplianceAcuity, Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | HWT |
| Regulation § (21 CFR) | 888.4800 |
| Proprietary names | TranS1 Anterior Cervical Plate System Instrument Set; TranS1 Spinal Fixation System Instrument Set; LnK Cervical Interbody Fusion Cage System Instrument Set; CastleLoc-C Cervical Interbody Fusion Cage System Instrument Set; PathLoc-SI Joint Fusion System Instrument Set; CastleLoc-P Anterior Cervical Plate System Instrument Set; LnK Anterior Cervical Plate System Instrument Set; LnK Spinal Fixation System Instrument Set; TranS1 MIS Spinal System Instrument Set; CastleLoc-S Posterior Cervical Fixation System Instrument Set |
Source: openFDA. Public-domain (CC0).