| BluEX Cervical Expandable Cage System (K260840) | L&K BIOMED Co., Ltd. | 2026-05-16 |
| CastleLoc-P Anterior Cervical Plate System (K261112) | L&K BIOMED Co., Ltd. | 2026-05-06 |
| AccelFix Spinal Fixation System (K261130) | L&K BIOMED Co., Ltd. | 2026-05-05 |
| CastleLoc Pectus Bar System (K260448) | L&K BIOMED Co., Ltd. | 2026-03-19 |
| PathLoc Lumbar Plate System (K251940) | L&K BIOMED Co., Ltd. | 2026-03-03 |
| PathLoc Lumbar Interbody Fusion Cage System (K251741) | L&K BIOMED Co., Ltd. | 2025-07-08 |
| CastleLoc Pectus Bar System (K250892) | L&K BIOMED Co., Ltd. | 2025-04-25 |
| CastleLoc Pectus Bar System (K243357) | L&K BIOMED Co., Ltd. | 2025-02-27 |
| BluEX Lumbar Expandable Cage System (K242829) | L&K BIOMED Co., Ltd. | 2024-10-23 |
| PathLoc SI Joint Fusion System (K240201) | L&K BIOMED Co., Ltd. | 2024-02-23 |
| AccelFix Lumbar Expandable Cage System (K231680) | L&K BIOMED Co., Ltd. | 2023-08-24 |
| LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System (K232311) | L&K BIOMED Co., Ltd. | 2023-08-14 |
| CastleLoc-S Posterior Cervical Fixation System (K231840) | L&K BIOMED Co., Ltd. | 2023-07-20 |
| CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System (K231839) | L&K BIOMED Co., Ltd. | 2023-07-19 |
| PathLoc SI Joint Fusion System (K231841) | L&K BIOMED Co., Ltd. | 2023-07-14 |
| LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. (K231636) | L&K BIOMED Co., Ltd. | 2023-06-27 |
| LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System (K230245) | L&K BIOMED Co., Ltd. | 2023-02-28 |
| PathLoc-TA Expandable Lumbar Cage System (K223474) | L&K BIOMED Co., Ltd. | 2023-01-13 |
| LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. (K223565) | L&K BIOMED Co., Ltd. | 2022-12-23 |
| PathLoc Lumbar Interbody Fusion Cage System (K213441) | L&K BIOMED Co., Ltd. | 2022-03-09 |
| LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System (K200789) | L&K BIOMED Co., Ltd. | 2020-12-04 |
| LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System (K200790) | L&K BIOMED Co., Ltd. | 2020-10-28 |
| AccelFix Spinal Fixation System (K200794) | L&K BIOMED Co., Ltd. | 2020-10-20 |
| LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System (K200793) | L&K BIOMED Co., Ltd. | 2020-10-08 |
| AccelFix Lumbar Plate System (K192481) | L&K BIOMED Co., Ltd. | 2020-07-28 |
| AccelFix Lumbar Interbody Fusion Cage System (K190708) | L&K BIOMED Co., Ltd. | 2019-09-16 |
| AccelFix Spinal Fixation System (K182544) | L&K BIOMED Co., Ltd. | 2019-05-28 |
| CastleLoc-P Anterior Cervical Plate System (K190425) | L&K BIOMED Co., Ltd. | 2019-03-21 |
| OpenLoc-L Spinal Fixation System (K183168) | L&K BIOMED Co., Ltd. | 2018-12-11 |
| PathLoc-L MIS Spinal System (K183117) | L&K BIOMED Co., Ltd. | 2018-11-15 |
| LnK Lumbar Interbody Fusion Cage System (K181380) | L&K BIOMED Co., Ltd. | 2018-09-11 |
| PathLoc-SI Joint Fusion System (K181600) | L&K BIOMED Co., Ltd. | 2018-07-16 |
| OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System (K171813) | L&K BIOMED Co., Ltd. | 2017-07-13 |
| PathLoc-SI Joint Fusion System (K153656) | L&K BIOMED Co., Ltd. | 2016-11-14 |
| CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System (K162136) | L&K BIOMED Co., Ltd. | 2016-11-03 |
| CastleLoc Spinal Fixation System (K162801) | L&K BIOMED Co., Ltd. | 2016-11-03 |
| PathLoc-L MIS Spinal System (K161766) | L&K BIOMED Co., Ltd. | 2016-08-22 |
| PathLoc-C Posterior Cervical Fixation System (K153439) | L&K BIOMED Co., Ltd. | 2016-07-21 |
| LnK Lumbar Interbody Fusion Cage System (K151140) | L&K BIOMED Co., Ltd. | 2015-08-18 |
| LnK Posterior Cervical Fixation System (K143278) | L&K BIOMED Co., Ltd. | 2015-07-29 |
| LnK Cervical Interbody Fusion Cage System (K151677) | L&K BIOMED Co., Ltd. | 2015-07-15 |
| CastleLoc-P Anterior Cervical Plate System (K143271) | L&K BIOMED Co., Ltd. | 2015-07-01 |
| VENUS Spinal Fixation System (K143363) | L&K BIOMED Co., Ltd. | 2015-04-22 |
| LnK Cervical Interbody Fusion Cage System (K143360) | L&K BIOMED Co., Ltd. | 2015-04-03 |
| LnK Anterior Cervical Plate System (K143279) | L&K BIOMED Co., Ltd. | 2015-03-20 |
| VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM (K121096) | L&K BIOMED Co., Ltd. | 2012-07-06 |
| LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM (K120840) | L&K BIOMED Co., Ltd. | 2012-05-24 |
| LEXUS CERVICAL FIXATION SYSTEM (K120879) | L&K BIOMED Co., Ltd. | 2012-05-23 |
| VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM (K120063) | L&K BIOMED Co., Ltd. | 2012-04-19 |
| VENUS SPINAL FIXATION SYSTEM (K120270) | L&K BIOMED Co., Ltd. | 2012-03-26 |
| FOCUS SPINAL SYSTEM (K120140) | L&K BIOMED Co., Ltd. | 2012-02-15 |
| LEXUS ANTERIOR CERVICAL PLATE SYSTEM (K113509) | L&K BIOMED Co., Ltd. | 2012-01-20 |
| FOCUS MIS SYSTEM (K112643) | L&K BIOMED Co., Ltd. | 2012-01-04 |
| VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE (K110783) | L&K BIOMED Co., Ltd. | 2011-10-24 |
| VENUS CERVICAL SPINAL FIXATION SYSTEM (K103414) | L&K BIOMED Co., Ltd. | 2011-07-22 |
| VENUS BASIC SPINAL FIXATION SYSTEM (K103085) | L&K BIOMED Co., Ltd. | 2011-02-09 |
| VENUS BASIC SPINAL FIXATION SYSTEM (K100706) | L&K BIOMED Co., Ltd. | 2010-07-22 |