510(k) Report

Devices descending from K130948

13 later devices reach C-Fuse Cervical Intervertebral Body Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+1K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+1K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+2K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+2K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+3K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+3K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+3K203444BEE HA CageNGMedical GmbH20211—
+4K250560BEE HANGMedical GmbH20250—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—