510(k) Report

Devices descending from K050439

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+4K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+4K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K201648Sterispine™ PSSafe Orthopaedics202011
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+4K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+4K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+4K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+4K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+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—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+4K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+4K173126Arisstos™ Spinal SystemIngenium Spine20171—
+4K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+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—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+4K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+4K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+4K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+4K162786PASS LP Spinal SystemMedicrea International SA20176—
+4K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+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—
+4K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+4K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+4K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+4K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+4K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+4K141044M.U.S.T. ExtensionMedacta International201416—
+4K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—