510(k) Report

Devices descending from K042962

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+6K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K241258Ingenix Spinal SystemIngenium Spine20240—
+6K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+6K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+6K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+6K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+6K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+6K223273ASTRA Spine SystemSpinecraft, LLC20228—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+6K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+6K221745Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20220—
+6K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+6K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+6K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+6K213918DeGen Navigated InstrumentationDegen Medical20220—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+6K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+6K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+6K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+6K203452Nano FortiFix® SystemNanovis, LLC20200—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+6K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+6K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+6K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+6K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+6K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+6K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+6K193219G Surgical Marksman SystemG Surgical, LLC20191—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+6K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+6K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+6K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+6K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+6K182240PASS LP Spinal SystemMedicrea International SA20182—
+6K181397DualXInnovasive, Inc.201815—
+6K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+6K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+6K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+6K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+6K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811