510(k) Report

Devices descending from K170271

12 later devices reach NuVasive (r) Monolith Corpectomy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated201811—
+2K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+2K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+2K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+2K191778Omnia Medical VBROmnia Medical, LLC20195—
+3K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+3K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+3K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+3K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—