LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System (K230245)
Description
LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System by L & K Biomed Co., Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230245
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System (K230245) cites 10 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223560 | Plato 17 Microcatheter | Scientia Vascular, Inc. | 2023 |
| K223565 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation Syste... | L&K BIOMED Co., Ltd. | 2022 |
| K200790 | LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System | L&K BIOMED Co., Ltd. | 2020 |
| K200794 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2020 |
| K182544 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2019 |
| K183168 | OpenLoc-L Spinal Fixation System | L&K BIOMED Co., Ltd. | 2018 |
| K181139 | OLYMPIC Posterior Spinal Fixation System | Astura Medical, LLC | 2018 |
| K171813 | OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System | L&K BIOMED Co., Ltd. | 2017 |
| K143363 | VENUS Spinal Fixation System | L&K BIOMED Co., Ltd. | 2015 |
| K120270 | VENUS SPINAL FIXATION SYSTEM | L&K BIOMED Co., Ltd. | 2012 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232311 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation Syste... | L&K BIOMED Co., Ltd. | 2023 |
| K231636 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation Syste... | L&K BIOMED Co., Ltd. | 2023 |
Trace the full predicate network for K230245
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.