510(k) Report

Devices descending from K041777

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+4K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+4K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+4K220486Kentrospine PSS Pedicle Screw SystemRivarp Medical Private Limited20220—
+4K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+4K210637CD Horizon™ Spinal SystemMedtronic202134—
+4K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+4K202505GetSet Surgical GoPLF! Posterior Lateral Fusion SystemGetset Surgical, SA20210—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K202771CD Horizon Spinal SystemMedtronic202021—
+4K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+4K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+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—
+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—
+4K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+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—
+4K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+4K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+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—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+4K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+4K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+4K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+4K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+4K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+4K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+4K173508Everest Spinal SystemK2m20189—
+4K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K171321K2M Navigation InstrumentsK2m201711
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171838TiLock2 Spinal SystemGenesys Spine20174—
+4K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+4K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+4K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+4K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+4K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+4K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+4K161627PASS LP Spinal SystemMedicrea International SA20167—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+4K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+4K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+4K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+4K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+4K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+4K150417Astra Spine SystemSpinecraft, LLC201521—
+4K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K143350Nile Alternative FixationK2m, Inc.201510—
+4K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—