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
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K203816DeGen Navigated InstrumentationDegen Medical20211—
+4K210472SPINEART Navigation Instrument SystemSpineart20215—
+4K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K201648Sterispine™ PSSafe Orthopaedics202011
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+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—
+4K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+4K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+4K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+4K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+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—
+4K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K173508Everest Spinal SystemK2m20189—
+4K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+4K173126Arisstos™ Spinal SystemIngenium Spine20171—
+4K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+4K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+4K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+4K162921Navigated Instrument SystemOrthofix, Inc.20175—
+4K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+4K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+4K161627PASS LP Spinal SystemMedicrea International SA20167—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+4K141044M.U.S.T. ExtensionMedacta International201416—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+4K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+4K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+4K132303Implanet Spine SystemImplanet, S.A.201315—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+4K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+4K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+4K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+4K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—