Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
L&K BIOMED Co., Ltd. · Predicate Candidate Screening
57 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
252 days90th percentile
57clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260840 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | 2026-05-16 | 61 | 0 |
| K261112 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2026-05-06 | 33 | 0 |
| K261130 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2026-05-05 | 29 | 0 |
| K260448 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2026-03-19 | 36 | 0 |
| K251940 | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | 2026-03-03 | 252 | 0 |
| K251741 | PathLoc Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2025-07-08 | 32 | 0 |
| K250892 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2025-04-25 | 31 | 0 |
| K243357 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2025-02-27 | 121 | 0 |
| K242829 | BluEX Lumbar Expandable Cage System | L&K BIOMED Co., Ltd. | 2024-10-23 | 34 | 0 |
| K240201 | PathLoc SI Joint Fusion System | L&K BIOMED Co., Ltd. | 2024-02-23 | 29 | 0 |
| K231680 | AccelFix Lumbar Expandable Cage System | L&K BIOMED Co., Ltd. | 2023-08-24 | 76 | 0 |
| K232311 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System | L&K BIOMED Co., Ltd. | 2023-08-14 | 12 | 0 |
| K231840 | CastleLoc-S Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | 2023-07-20 | 28 | 0 |
| K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar | L&K BIOMED Co., Ltd. | 2023-07-19 | 27 | 0 |
| K231841 | PathLoc SI Joint Fusion System | L&K BIOMED Co., Ltd. | 2023-07-14 | 22 | 0 |
| K231636 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System | L&K BIOMED Co., Ltd. | 2023-06-27 | 22 | 0 |
| K230245 | LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; | L&K BIOMED Co., Ltd. | 2023-02-28 | 29 | 0 |
| K223474 | PathLoc-TA Expandable Lumbar Cage System | L&K BIOMED Co., Ltd. | 2023-01-13 | 56 | 0 |
| K223565 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System | L&K BIOMED Co., Ltd. | 2022-12-23 | 24 | 0 |
| K213441 | PathLoc Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2022-03-09 | 135 | 0 |
| K200789 | LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix | L&K BIOMED Co., Ltd. | 2020-12-04 | 253 | 0 |
| K200790 | LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System | L&K BIOMED Co., Ltd. | 2020-10-28 | 216 | 0 |
| K200794 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2020-10-20 | 208 | 0 |
| K200793 | LnK Posterior Cervical Fixation System and CastleLoc-S Poste | L&K BIOMED Co., Ltd. | 2020-10-08 | 196 | 0 |
| K192481 | AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | 2020-07-28 | 322 | 0 |
| K190708 | AccelFix Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2019-09-16 | 181 | 0 |
| K182544 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2019-05-28 | 253 | 0 |
| K190425 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2019-03-21 | 27 | 0 |
| K183168 | OpenLoc-L Spinal Fixation System | L&K BIOMED Co., Ltd. | 2018-12-11 | 25 | 0 |
| K183117 | PathLoc-L MIS Spinal System | L&K BIOMED Co., Ltd. | 2018-11-15 | 6 | 0 |
| K181380 | LnK Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2018-09-11 | 110 | 0 |
| K181600 | PathLoc-SI Joint Fusion System | L&K BIOMED Co., Ltd. | 2018-07-16 | 28 | 0 |
| K171813 | OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System | L&K BIOMED Co., Ltd. | 2017-07-13 | 24 | 0 |
| K153656 | PathLoc-SI Joint Fusion System | L&K BIOMED Co., Ltd. | 2016-11-14 | 329 | 0 |
| K162136 | CastleLoc-S Posterior Cervical Fixation System; LnK Posterio | L&K BIOMED Co., Ltd. | 2016-11-03 | 94 | 0 |
| K162801 | CastleLoc Spinal Fixation System | L&K BIOMED Co., Ltd. | 2016-11-03 | 29 | 0 |
| K161766 | PathLoc-L MIS Spinal System | L&K BIOMED Co., Ltd. | 2016-08-22 | 56 | 0 |
| K153439 | PathLoc-C Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | 2016-07-21 | 237 | 0 |
| K151140 | LnK Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2015-08-18 | 111 | 0 |
| K143278 | LnK Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | 2015-07-29 | 257 | 0 |
| K151677 | LnK Cervical Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2015-07-15 | 23 | 0 |
| K143271 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2015-07-01 | 230 | 0 |
| K143363 | VENUS Spinal Fixation System | L&K BIOMED Co., Ltd. | 2015-04-22 | 149 | 0 |
| K143360 | LnK Cervical Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2015-04-03 | 130 | 0 |
| K143279 | LnK Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2015-03-20 | 126 | 0 |
| K121096 | VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM | L&K BIOMED Co., Ltd. | 2012-07-06 | 86 | 0 |
| K120840 | LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM | L&K BIOMED Co., Ltd. | 2012-05-24 | 65 | 0 |
| K120879 | LEXUS CERVICAL FIXATION SYSTEM | L&K BIOMED Co., Ltd. | 2012-05-23 | 61 | 0 |
| K120063 | VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM | L&K BIOMED Co., Ltd. | 2012-04-19 | 101 | 0 |
| K120270 | VENUS SPINAL FIXATION SYSTEM | L&K BIOMED Co., Ltd. | 2012-03-26 | 56 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda