FDA 510(k) Applications Submitted by Yerim An
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K151140 |
04/29/2015 |
LnK Lumbar Interbody Fusion Cage System |
L&K BIOMED Co., Ltd |
| K171813 |
06/19/2017 |
OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System |
L&K BIOMED Co., Ltd. |
| K151677 |
06/22/2015 |
LnK Cervical Interbody Fusion Cage System |
L&K BIOMED Co.,Ltd. |
| K161766 |
06/27/2016 |
PathLoc-L MIS Spinal System |
L&K BIOMED Co., Ltd. |
| K162136 |
08/01/2016 |
CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System |
L&K BIOMED CO.,LTD. |
| K162801 |
10/05/2016 |
CastleLoc Spinal Fixation System |
L&K BIOMED CO., LTD. |
| K143360 |
11/24/2014 |
LnK Cervical Interbody Fusion Cage 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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