510(k) Report

Devices descending from K140864

9 later devices reach Veloxtm Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183243Velofix TLIF CageU&I Corporation20190—
+1K172419Velofix™ TLIF CageU&I Corporation20172—
+1K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+2K201793EDEN Peek CageJmt Co., Ltd.20210—
+2K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+2K181829Velofix TLIF CageU&I Corporation20181—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+4K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+4K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—