FDA 510(k) Applications Submitted by Kihyang Kim
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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. |
| K221050 |
04/11/2022 |
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System |
Aegis Spine, Inc. |
| K221719 |
06/13/2022 |
ABTross ALIF Expandable Cage System |
Aegis Spine, Inc. |
| K192481 |
09/10/2019 |
AccelFix Lumbar Plate System |
L&K Biomed Co., Ltd. |
| K223521 |
11/23/2022 |
ZESPIN SI Joint Fusion System |
Aegis Spine, Inc. |
| K223719 |
12/12/2022 |
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System |
Aegis Spine, Inc. |
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