510(k) Report

Devices descending from K091445

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+1K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+1K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+1K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+1K141044M.U.S.T. ExtensionMedacta International201416—
+1K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+1K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+1K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+1K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+1K132878M.U.S.T. ExtensionMedacta International201328—
+1K132303Implanet Spine SystemImplanet, S.A.201315—
+1K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+1K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+1K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+1K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc.2013181
+1K130655Response Spine SystemOrthoPediatrics Corp.201317—
+1K122877Range Spinal System, Small StatureK2m, Inc.201334—
+1K121630Range Spinal SystemK2m, Inc.2012127—
+1K113666Xia 3 Spinal SystemStryker Spine2012251—
+1K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+1K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+1K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+1K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+1K111457CD Horizon Spinal SystemMedtronic Sofamor Danek2011261—
+1K110348Universal Clamp Spinal Fixation SystemZimmer Spine201144—
+1K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc.2011269—
+1K101471Axle Interspinous Fusion SystemX-Spine Systems, Inc.2010261
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+2K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+2K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+2K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+2K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+2K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+2K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine20230—
+2K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+2K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+2K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+2K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+2K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+2K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+2K172206NAJA™ Ligament Correction SystemCousin Biotech Sas20182—
+2K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+2K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+2K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+2K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+2K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+2K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+2K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+2K170647Connector SystemOrthofix, Inc.201718—
+2K162764Jazz Frame SystemImplanet, S.A.20176—
+2K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+2K161267Response BandLoc Spinal FixationOrthoPediatrics Corp.201611
+2K161028K2M Growing Spine SystemK2m, Inc.20163—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+2K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+2K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+2K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+2K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+2K151974Polaris Spinal SystemBiomet Spine201516—
+2K143631Benefix Interspinous Fixation SystemU&I Corporation20150—
+2K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+2K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+2K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20152—
+2K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+2K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+2K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+2K143388Affix IIS Spinous Process Plate SystemNu Vasive, Incorporated20150—
+2K143350Nile Alternative FixationK2m, Inc.201510—
+2K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+2K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+2K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159—
+2K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+2K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+2K142053Universal Clamp Spinal Fixation SystemZimmer Spine, Inc.201423—
+2K142381Xia 3 Spinal SystemStryker Corp.201483—
+2K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+2K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+2K141508Romeo 2 Pad Posterior Axial DeviceSpineart20141—
+2K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—