510(k) Report

Devices descending from K150765

59 later devices reach LDR Spine ROI-C Cervical Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+1K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+1K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+1K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+1K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+1K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+1K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+2K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+2K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+2K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+2K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+2K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+2K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+2K180909REVEL SpacersGlobus Medical, Inc.201837—
+2K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+2K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+3K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K261279DeltaNEC Interbody SystemNexus Spine20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K260660SABER-C SystemElevation Spine20261—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K250540SABER-C SystemElevation Spine20252—
+4K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+4K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K263049SABER-C SystemElevation Spine20260—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—