510(k) Report

Devices descending from K102807

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+6K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+6K243249TriALTIS™ Spine SystemMedos International SARL20250—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K243693NEO Pedicle Screw System™Neo Medical SA20240—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K241258Ingenix Spinal SystemIngenium Spine20240—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K233684TriALTIS™ Spine SystemMedos International SARL20234—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K231658VEOS Spinal Fixation SystemSpineway20230—
+6K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K223273ASTRA Spine SystemSpinecraft, LLC20228—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+6K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+6K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+6K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+6K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+6K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+6K200896Solstice CCILife Spine, Inc.20200—
+6K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+6K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+6K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+6K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+6K190751Connector SystemOrthofix, Inc.20193—
+6K182470Plateau Spacer SystemLife Spine20180—
+6K182182YUKON OCT Spinal SystemK2m20185—
+6K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+7K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+7K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+7K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K242042TriALTIS™ Spine SystemMedos International SARL20241—
+7K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K230989Rod Registration FrameNu Vasive, Incorporated20230—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+7K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+7K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+7K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—