510(k) Report

Devices descending from K210035

10 later devices reach ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System… through their predicates, nearest generation first.

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