510(k) Report

Devices descending from K001794

13 later devices reach Ebi Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190666CYGNUS™ Anterior Cervical Plate SystemMiRus, LLC20192—
+1K173306EZ PlateZavation Medical Products, LLC20180—
+1K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd.20174—
+1K140361Meta-C Cervical PlateMedacta International20140—
+1K112809Blue Mountain Cervical PlateQualgenix, LLC20122—
+2K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+2K220441CYGNUS™ MoRe Anterior Cervical Plate SystemMiRus, LLC20221—
+2K220379IMPEACE and IMPEACE-Uni Anterior Cervical Plate SystemMedynus, Inc.20220—
+2K150036Blue Mountain Cervical Plate SystemSpineway20151—
+3K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+3K241175MiRus MoRe Lumbar Plating SystemMiRus, LLC20240—
+3K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+3K163602Kepler I Cervical Plate SystemOrbbo Surgical, LLC20170—