510(k) Report

Devices descending from K951389

19 later devices reach Reunion Bone Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163303OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC20173—
+1K112240Dyna Locking Cannulated ScrewU&I Corp.201214—
+2K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+2K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+2K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201613—
+3K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+3K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+3K203373Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLC20210—
+3K181600PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201811—
+4K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+6K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+6K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+6K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—