510(k) Report

Devices descending from K191778

5 later devices reach Omnia Medical VBR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+1K202637F3D Corpectomy SystemCorelink, LLC20201—
+1K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+2K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+2K230329F3D Interbody SystemCorelink, LLC20230—