510(k) Report

Devices descending from K192117

6 later devices reach Small VBR™ through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+1K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+1K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+2K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+2K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+3K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—