510(k) Report

Devices descending from K181600

11 later devices reach PathLoc-SI Joint Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+1K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+2K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+2K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+2K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+2K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+2K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+2K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+3K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+3K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+3K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—