L&K BIOMED Co., Ltd.
L&K BIOMED Co., Ltd. has 0 FDA recalls, 2 inspections, 59 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jan 26, 2017 · OAI
- Latest 510(k)
- Aug 18, 2026
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 59 | Oct 4, 2026 | Not stated | Current |
| Inspections | 2 | Oct 25, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 26, 2017 | Yongin-Si, Korea (The Republic Of) | Devices | Official Action Indicated (OAI) | 3008285983 |
| Jun 5, 2014 | Yongin-Si, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3008285983 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K262489 | BluEX Cervical Expandable Cage System | Aug 18, 2026 |
| K260840 | BluEX Cervical Expandable Cage System | May 16, 2026 |
| K261112 | CastleLoc-P Anterior Cervical Plate System | May 6, 2026 |
| K261130 | AccelFix Spinal Fixation System | May 5, 2026 |
| K260448 | CastleLoc Pectus Bar System | Mar 19, 2026 |
| K251940 | PathLoc Lumbar Plate System | Mar 3, 2026 |
| K251741 | PathLoc Lumbar Interbody Fusion Cage System | Jul 8, 2025 |
| K250892 | CastleLoc Pectus Bar System | Apr 25, 2025 |
| K243357 | CastleLoc Pectus Bar System | Feb 27, 2025 |
| K242829 | BluEX Lumbar Expandable Cage System | Oct 23, 2024 |
| K240201 | PathLoc SI Joint Fusion System | Feb 23, 2024 |
| K231680 | AccelFix Lumbar Expandable Cage System | Aug 24, 2023 |
| K232311 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System | Aug 14, 2023 |
| K231840 | CastleLoc-S Posterior Cervical Fixation System | Jul 20, 2023 |
| K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | Jul 19, 2023 |
| K231841 | PathLoc SI Joint Fusion System | Jul 14, 2023 |
| K231636 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. | Jun 27, 2023 |
| K230245 | LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System | Feb 28, 2023 |
| K223474 | PathLoc-TA Expandable Lumbar Cage System | Jan 13, 2023 |
| K223565 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. | Dec 23, 2022 |