510(k) Report

Devices descending from K103488

29 later devices reach Concorde Bullet Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+1K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+1K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+1K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+2K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+2K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+2K181397DualXInnovasive, Inc.201815—
+2K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+3K211740DualXAmplify Surgical, Inc.20211—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+3K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+5K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+5K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—