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L & K Biomed Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
53
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251940PathLoc Lumbar Plate SystemMarch 3, 2026
K251741PathLoc Lumbar Interbody Fusion Cage SystemJuly 8, 2025
K250892CastleLoc Pectus Bar SystemApril 25, 2025
K243357CastleLoc Pectus Bar SystemFebruary 27, 2025
K242829BluEX Lumbar Expandable Cage SystemOctober 23, 2024
K240201PathLoc SI Joint Fusion SystemFebruary 23, 2024
K231680AccelFix Lumbar Expandable Cage SystemAugust 24, 2023
K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation SystemAugust 14, 2023
K231840CastleLoc-S Posterior Cervical Fixation SystemJuly 20, 2023
K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemJuly 19, 2023
K231841PathLoc SI Joint Fusion SystemJuly 14, 2023
K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.June 27, 2023
K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation SystemFebruary 28, 2023
K223474PathLoc-TA Expandable Lumbar Cage SystemJanuary 13, 2023
K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.December 23, 2022
K213441PathLoc Lumbar Interbody Fusion Cage SystemMarch 9, 2022
K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemDecember 4, 2020
K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemOctober 28, 2020
K200794AccelFix Spinal Fixation SystemOctober 20, 2020
K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemOctober 8, 2020