510(k) Report

Devices descending from K120966

25 later devices reach Depuy Pulse Lumbar Cage System through their predicates, nearest generation first.

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