510(k) Report

Devices descending from K031655

1,220 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+4K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K203816DeGen Navigated InstrumentationDegen Medical20211—
+4K210472SPINEART Navigation Instrument SystemSpineart20215—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K202505GetSet Surgical GoPLF! Posterior Lateral Fusion SystemGetset Surgical, SA20210—
+4K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+4K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+4K201648Sterispine™ PSSafe Orthopaedics202011
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+4K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+4K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+4K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+4K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+4K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+4K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+4K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+4K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+4K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+4K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+4K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+4K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+4K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+4K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+4K181188EVEREST Spinal SystemK2m, Inc.20186—
+4K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+4K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+4K173508Everest Spinal SystemK2m20189—
+4K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+4K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+4K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+4K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+4K171838TiLock2 Spinal SystemGenesys Spine20174—
+4K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+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—
+4K162921Navigated Instrument SystemOrthofix, Inc.20175—
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+4K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+4K162786PASS LP Spinal SystemMedicrea International SA20176—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+4K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—