510(k) Report

Devices descending from K051674

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222698CUVIS-spineCurexo, Inc.20220—
+6K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+6K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+6K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+6K213918DeGen Navigated InstrumentationDegen Medical20220—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+6K211323ASTRA Spine SystemSpinecraft, LLC202112—
+6K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+6K210306GII Spinal Fixation SystemColigne AG20210—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+6K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+6K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+6K200896Solstice CCILife Spine, Inc.20200—
+6K193129Yukon OCT Spinal SystemK2m, Inc.202001
+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—
+6K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+6K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+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—
+6K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+6K161149PASS OCT Spinal SystemMedicrea International SA20160—
+6K160756PASS OCT Spinal SystemMedicrea International SA20160—
+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—
+6K153169PASS OCT Patient Specific RodsMedicrea International20164—
+6K152211PCT SystemCentinel Spine, Inc.20150—
+6K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+6K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+6K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+6K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+6K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+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—
+7K254274ARx® SAI Implant SystemLife Spine, 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—
+7K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+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—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+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—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+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—
+7K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+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—