510(k) Report

Devices descending from K170395

10 later devices reach Talos® Lumbar (HA) PEEK IBF Devices through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+1K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+1K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+2K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+2K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+3K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—