510(k) Report

Devices descending from K041862

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K201648Sterispine™ PSSafe Orthopaedics202011
+5K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+5K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K181397DualXInnovasive, Inc.201815—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+5K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+5K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+5K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+5K180324Patriot Spinal Fixation SystemValorus Spine20180—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+5K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K173126Arisstos™ Spinal SystemIngenium Spine20171—
+5K172469TiLock Modular Spinal SystemGenesys Spine20170—
+5K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+5K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+5K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+5K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+5K162921Navigated Instrument SystemOrthofix, Inc.20175—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K160640PASS XS Spinal SystemMedicrea International SA20160—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+5K161028K2M Growing Spine SystemK2m, Inc.20163—
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K153413PASS LP Spinal SystemMedicrea International SA20160—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+5K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+5K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+5K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—