510(k) Report

Devices descending from K091974

656 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+4K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+4K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K162764Jazz Frame SystemImplanet, S.A.20176—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+4K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+4K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+4K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+4K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+4K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+4K142499Reline SystemNu Vasive, Incorporated201478—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+5K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K253249TriALTIS™ Spine SystemMedos International SARL20251—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243249TriALTIS™ Spine SystemMedos International SARL20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243693NEO Pedicle Screw System™Neo Medical SA20240—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K233300POWEReam 1/4 DriveStryker Instruments20231—
+5K233684TriALTIS™ Spine SystemMedos International SARL20234—
+5K231515MySpine Cervical GuidesMedacta International S.A.20230—
+5K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+5K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+5K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K231658VEOS Spinal Fixation SystemSpineway20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+5K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+5K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+5K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+5K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+5K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+5K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+5K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+5K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—