510(k) Report

Devices descending from K190067

3 later devices reach Velofix Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+2K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+2K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—