FDA 510(k) Applications Submitted by L&K BIOMED Co., Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K143278 |
11/14/2014 |
LnK Posterior Cervical Fixation System |
L&K BIOMED Co., Ltd. |
| K190425 |
02/22/2019 |
CastleLoc-P Anterior Cervical Plate System |
L&K BIOMED Co., Ltd. |
| K190708 |
03/19/2019 |
AccelFix Lumbar Interbody Fusion Cage System |
L&K Biomed Co., Ltd. |
| K181380 |
05/24/2018 |
LnK Lumbar Interbody Fusion Cage System |
L&K BIOMED Co., Ltd. |
| K181600 |
06/18/2018 |
PathLoc-SI Joint Fusion System |
L&K BIOMED Co., Ltd. |
| K182544 |
09/17/2018 |
AccelFix Spinal Fixation System |
L&K BioMed Co., Ltd. |
| K183117 |
11/09/2018 |
PathLoc-L MIS Spinal System |
L&K Biomed Co., Ltd. |
| K183168 |
11/16/2018 |
OpenLoc-L Spinal Fixation System |
L&K Biomed Co., Ltd. |
| K213441 |
10/25/2021 |
PathLoc Lumbar Interbody Fusion Cage System |
L&K BioMed Co., Ltd. |
| K230245 |
01/30/2023 |
LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System |
L&K BIOMED Co., Ltd. |
| K231636 |
06/05/2023 |
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. |
L&K BIOMED Co., Ltd. |
| K231680 |
06/09/2023 |
AccelFix Lumbar Expandable Cage System |
L&K BioMed Co., Ltd. |
| K232311 |
08/02/2023 |
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System |
L&K Biomed Co., Ltd. |
| K223474 |
11/18/2022 |
PathLoc-TA Expandable Lumbar Cage System |
L&K Biomed Co., Ltd. |
| K223565 |
11/29/2022 |
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. |
L&K Biomed Co., Ltd. |
| K143279 |
11/14/2014 |
LnK Anterior Cervical Plate System |
L&K BIOMED Co., Ltd. |
| K143363 |
11/24/2014 |
VENUS Spinal Fixation System |
L&K BIOMED Co., Ltd. |
| K250892 |
03/25/2025 |
CastleLoc Pectus Bar System |
L&K Biomed Co., Ltd. |
| K251741 |
06/06/2025 |
PathLoc Lumbar Interbody Fusion Cage System |
L&K BIOMED Co., Ltd. |
| K240201 |
01/25/2024 |
PathLoc SI Joint Fusion System |
L&K Biomed Co., Ltd. |
| K200789 |
03/26/2020 |
LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System |
L&K BIOMED Co., Ltd. |
| K200790 |
03/26/2020 |
LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System |
L&K BIOMED Co., Ltd. |
| K200793 |
03/26/2020 |
LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System |
L&K BIOMED Co., Ltd. |
| K200794 |
03/26/2020 |
AccelFix Spinal Fixation System |
L&K BIOMED Co., Ltd. |
| K192481 |
09/10/2019 |
AccelFix Lumbar Plate System |
L&K Biomed Co., Ltd. |
| K242829 |
09/19/2024 |
BluEX Lumbar Expandable Cage System |
L&K BIOMED Co., Ltd. |
| K243357 |
10/29/2024 |
CastleLoc Pectus Bar System |
L&K BIOMED Co., Ltd. |
| K171813 |
06/19/2017 |
OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System |
L&K BIOMED Co., Ltd. |
| K161766 |
06/27/2016 |
PathLoc-L MIS Spinal System |
L&K BIOMED Co., Ltd. |
| K162801 |
10/05/2016 |
CastleLoc Spinal Fixation System |
L&K BIOMED CO., LTD. |
| K153439 |
11/27/2015 |
PathLoc-C Posterior Cervical Fixation System |
L&K BIOMED CO., LTD. |
| K153656 |
12/21/2015 |
PathLoc-SI Joint Fusion System |
L&K BIOMED Co., Ltd. |
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