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L&K BIOMED Co., Ltd.

FDA 510(k) & PMA Approved Devices — 38 products

Total Devices38
Categories8
Latest FDA decision2026-05-16
TypeNumberDevice NameCodeDateActions
510(k) K260840 BluEX Cervical Expandable Cage SystemODP2026-05-16 View
510(k) K261112 CastleLoc-P Anterior Cervical Plate SystemKWQ2026-05-06 View
510(k) K261130 AccelFix Spinal Fixation SystemNKB2026-05-05 View
510(k) K260448 CastleLoc Pectus Bar SystemHRS2026-03-19 View
510(k) K251940 PathLoc Lumbar Plate SystemKWQ2026-03-03 View
510(k) K251741 PathLoc Lumbar Interbody Fusion Cage SystemMAX2025-07-08 View
510(k) K250892 CastleLoc Pectus Bar SystemHRS2025-04-25 View
510(k) K243357 CastleLoc Pectus Bar SystemHRS2025-02-27 View
510(k) K242829 BluEX Lumbar Expandable Cage SystemMAX2024-10-23 View
510(k) K240201 PathLoc SI Joint Fusion SystemOUR2024-02-23 View
510(k) K231680 AccelFix Lumbar Expandable Cage SystemMAX2023-08-24 View
510(k) K232311 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation SystemNKB2023-08-14 View
510(k) K231840 CastleLoc-S Posterior Cervical Fixation SystemNKG2023-07-20 View
510(k) K231839 CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemKWQ2023-07-19 View
510(k) K231841 PathLoc SI Joint Fusion SystemOUR2023-07-14 View
510(k) K231636 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.NKB2023-06-27 View
510(k) K230245 LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation SystemNKB2023-02-28 View
510(k) K223474 PathLoc-TA Expandable Lumbar Cage SystemMAX2023-01-13 View
510(k) K223565 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.NKB2022-12-23 View
510(k) K213441 PathLoc Lumbar Interbody Fusion Cage SystemMAX2022-03-09 View

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