510(k) Report

Devices descending from K121680

357 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200896Solstice CCILife Spine, Inc.20200—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K190376PASS LP Spinal SystemMedicrea International SA201915
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+8K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K232628VADER® Pedicle SystemIcotec AG20241—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+8K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+8K222698CUVIS-spineCurexo, Inc.20220—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+9K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+10K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—