510(k) Report

Devices descending from K191477

10 later devices reach AEON-C Stand Alone System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241846E3D™-C Interbody SystemEvolution Spine20246—
+1K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+2K262094E3D™-C Interbody SystemEvolution Spine20260—
+2K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+2K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+2K260038E3D™-C Interbody SystemEvolution Spine20261—
+2K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+2K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+3K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—