Company ยท KR
L&K BIOMED Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2026. Name variants (Inc, Corp, punctuation) are merged.
58510(k) clearances (6 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 17 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 11 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 8 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 5 |
| NKG | Posterior Cervical Screw System | 4 |
| OUR | Sacroiliac Joint Fixation | 4 |
| HRS | Plate, Fixation, Bone | 3 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 |
| MNI | Orthosis, Spinal Pedicle Fixation | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 18, 2026 | K262489 | BluEX Cervical Expandable Cage System L&K BIOMED Co., Ltd., KR | ODP |
| May 16, 2026 | K260840 | BluEX Cervical Expandable Cage System L&K BIOMED Co., Ltd., KR | ODP |
| May 6, 2026 | K261112 | CastleLoc-P Anterior Cervical Plate System L&K BIOMED Co., Ltd., KR | KWQ |
| May 5, 2026 | K261130 | AccelFix Spinal Fixation System L&K BIOMED Co., Ltd., KR | NKB |
| Mar 19, 2026 | K260448 | CastleLoc Pectus Bar System L&K BIOMED Co., Ltd., KR | HRS |
| Mar 3, 2026 | K251940 | PathLoc Lumbar Plate System L&K BIOMED Co., Ltd., KR | KWQ |
| Jul 8, 2025 | K251741 | PathLoc Lumbar Interbody Fusion Cage System L&K BIOMED Co., Ltd., KR | MAX |
| Apr 25, 2025 | K250892 | CastleLoc Pectus Bar System L&K BIOMED Co., Ltd., KR | HRS |
| Feb 27, 2025 | K243357 | CastleLoc Pectus Bar System L&K BIOMED Co., Ltd., KR | HRS |
| Oct 23, 2024 | K242829 | BluEX Lumbar Expandable Cage System L&K BIOMED Co., Ltd., KR | MAX |
| Feb 23, 2024 | K240201 | PathLoc SI Joint Fusion System L&K BIOMED Co., Ltd., KR | OUR |
| Aug 24, 2023 | K231680 | AccelFix Lumbar Expandable Cage System L&K BIOMED Co., Ltd., KR | MAX |
| Aug 14, 2023 | K232311 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System L&K BIOMED Co., Ltd., KR | NKB |
| Jul 20, 2023 | K231840 | CastleLoc-S Posterior Cervical Fixation System L&K BIOMED Co., Ltd., KR | NKG |
| Jul 19, 2023 | K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System L&K BIOMED Co., Ltd., KR | KWQ |
| Jul 14, 2023 | K231841 | PathLoc SI Joint Fusion System L&K BIOMED Co., Ltd., KR | OUR |
| Jun 27, 2023 | K231636 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. L&K BIOMED Co., Ltd., KR | NKB |
| Feb 28, 2023 | K230245 | LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System L&K BIOMED Co., Ltd., KR | NKB |
| Jan 13, 2023 | K223474 | PathLoc-TA Expandable Lumbar Cage System L&K BIOMED Co., Ltd., KR | MAX |
| Dec 23, 2022 | K223565 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. L&K BIOMED Co., Ltd., KR | NKB |
| Mar 9, 2022 | K213441 | PathLoc Lumbar Interbody Fusion Cage System L&K BIOMED Co., Ltd., KR | MAX |
| Dec 4, 2020 | K200789 | LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System L&K BIOMED Co., Ltd., KR | NKB |
| Oct 28, 2020 | K200790 | LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System L&K BIOMED Co., Ltd., KR | NKB |
| Oct 20, 2020 | K200794 | AccelFix Spinal Fixation System L&K BIOMED Co., Ltd., KR | NKB |
| Oct 8, 2020 | K200793 | LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System L&K BIOMED Co., Ltd., KR | NKG |
| Jul 28, 2020 | K192481 | AccelFix Lumbar Plate System L&K BIOMED Co., Ltd., KR | KWQ |
| Sep 16, 2019 | K190708 | AccelFix Lumbar Interbody Fusion Cage System L&K BIOMED Co., Ltd., KR | MAX |
| May 28, 2019 | K182544 | AccelFix Spinal Fixation System L&K BIOMED Co., Ltd., KR | NKB |
| Mar 21, 2019 | K190425 | CastleLoc-P Anterior Cervical Plate System L&K BIOMED Co., Ltd., KR | KWQ |
| Dec 11, 2018 | K183168 | OpenLoc-L Spinal Fixation System L&K BIOMED Co., Ltd., KR | NKB |
| Nov 15, 2018 | K183117 | PathLoc-L MIS Spinal System L&K BIOMED Co., Ltd., KR | NKB |
| Sep 11, 2018 | K181380 | LnK Lumbar Interbody Fusion Cage System L&K BIOMED Co., Ltd., KR | MAX |
| Jul 16, 2018 | K181600 | PathLoc-SI Joint Fusion System L&K BIOMED Co., Ltd., KR | OUR |
| Jul 13, 2017 | K171813 | OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System L&K BIOMED Co., Ltd., KR | NKB |
| Nov 14, 2016 | K153656 | PathLoc-SI Joint Fusion System L&K BIOMED Co., Ltd., KR | OUR |
| Nov 3, 2016 | K162801 | CastleLoc Spinal Fixation System L&K BIOMED Co., Ltd., KR | MNH |
| Nov 3, 2016 | K162136 | CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System L&K BIOMED Co., Ltd., KR | NKG |
| Aug 22, 2016 | K161766 | PathLoc-L MIS Spinal System L&K BIOMED Co., Ltd., KR | NKB |
| Jul 21, 2016 | K153439 | PathLoc-C Posterior Cervical Fixation System L&K BIOMED Co., Ltd., KR | NKG |
| Aug 18, 2015 | K151140 | LnK Lumbar Interbody Fusion Cage System L&K BIOMED Co., Ltd., KR | MAX |
| Jul 29, 2015 | K143278 | LnK Posterior Cervical Fixation System L&K BIOMED Co., Ltd., KR | KWP |
| Jul 15, 2015 | K151677 | LnK Cervical Interbody Fusion Cage System L&K BIOMED Co., Ltd., KR | ODP |
| Jul 1, 2015 | K143271 | CastleLoc-P Anterior Cervical Plate System L&K BIOMED Co., Ltd., KR | KWQ |
| Apr 22, 2015 | K143363 | VENUS Spinal Fixation System L&K BIOMED Co., Ltd., KR | NKB |
| Apr 3, 2015 | K143360 | LnK Cervical Interbody Fusion Cage System L&K BIOMED Co., Ltd., KR | ODP |
| Mar 20, 2015 | K143279 | LnK Anterior Cervical Plate System L&K BIOMED Co., Ltd., KR | KWQ |
| Jul 6, 2012 | K121096 | VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM L&K BIOMED Co., Ltd., KR | MAX |
| May 24, 2012 | K120840 | LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM L&K BIOMED Co., Ltd., KR | ODP |
| May 23, 2012 | K120879 | LEXUS CERVICAL FIXATION SYSTEM L&K BIOMED Co., Ltd., KR | MNI |
| Apr 19, 2012 | K120063 | VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM L&K BIOMED Co., Ltd., KR | MAX |
Newest 50 of 58.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||