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. |
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. |
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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