510(k) Report

Devices descending from K042790

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+6K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+6K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+6K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+6K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+6K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K173126Arisstos™ Spinal SystemIngenium Spine20171—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+6K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+6K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+6K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+6K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+6K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+6K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+7K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+7K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+7K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+7K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+7K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K243693NEO Pedicle Screw System™Neo Medical SA20240—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K241258Ingenix Spinal SystemIngenium Spine20240—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K223273ASTRA Spine SystemSpinecraft, LLC20228—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+7K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K200896Solstice CCILife Spine, Inc.20200—
+7K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+7K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+7K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+8K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—