510(k) Report

Devices descending from K221050

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+1K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+1K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+2K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+3K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+3K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—