510(k) Report

Devices descending from K052187

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+5K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+5K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241258Ingenix Spinal SystemIngenium Spine20240—
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+5K240392JAZZ Spinal SystemImplanet20241—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K231479TriALTIS Spine SystemMedos International SARL20238—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+5K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+5K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+5K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+5K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K223273ASTRA Spine SystemSpinecraft, LLC20228—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K221745Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20220—
+5K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+5K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+5K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K213918DeGen Navigated InstrumentationDegen Medical20220—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+5K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+5K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+5K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+5K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—