510(k) Report

Devices descending from K190025

6 later devices reach EVOL® -SI Joint Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+1K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+2K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+2K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+2K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+2K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—