510(k) Report

Devices descending from K040962

1,130 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K220486Kentrospine PSS Pedicle Screw SystemRivarp Medical Private Limited20220—
+4K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+4K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+4K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+4K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+4K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+4K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+4K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+4K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+4K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+4K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+4K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+4K183381Navigation Enabled InstrumentsStryker20191—
+4K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+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—
+4K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+4K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+4K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+4K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+4K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+4K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+4K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+4K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+4K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+4K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+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—
+4K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K171321K2M Navigation InstrumentsK2m201711
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+4K171838TiLock2 Spinal SystemGenesys Spine20174—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+4K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+4K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+4K162764Jazz Frame SystemImplanet, S.A.20176—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K160640PASS XS Spinal SystemMedicrea International SA20160—
+4K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+4K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+4K161627PASS LP Spinal SystemMedicrea International SA20167—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+4K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+4K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—