FDA 510(k) Applications Submitted by Katherine Kim

FDA 510(k) Number Submission Date Device Name Applicant
K230245 01/30/2023 LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System L&K BIOMED Co., Ltd.
K231636 06/05/2023 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. L&K BIOMED Co., Ltd.
K231680 06/09/2023 AccelFix Lumbar Expandable Cage System L&K BioMed Co., Ltd.
K231839 06/22/2023 CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System L & K Biomed Co., Ltd.
K231840 06/22/2023 CastleLoc-S Posterior Cervical Fixation System L & K Biomed Co., Ltd.
K231841 06/22/2023 PathLoc SI Joint Fusion System L & K Biomed Co., Ltd.
K232311 08/02/2023 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System L&K Biomed Co., Ltd.
K223474 11/18/2022 PathLoc-TA Expandable Lumbar Cage System L&K Biomed Co., Ltd.
K223565 11/29/2022 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. L&K Biomed Co., Ltd.


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