510(k) Report

Devices descending from K091445

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K141147Range Spinal SystemK2m, Inc.20141—
+2K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+2K133482Silc Fixation SystemGlobus Medical, Inc.201411—
+2K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+2K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+2K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+2K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+2K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+2K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+2K132395LigapassMedicrea International201323—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K132757Everest Spinal SystemK2m, Inc.201341—
+2K132287Jazz SystemHogan Lovells US LLP201315—
+2K131784Range Spinal SystemK2m, Inc.201334—
+2K124014Surefix Interspinous Fusion SystemJg Spine, LLC20130—
+2K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+2K130330Range Spinal SystemK2m, Inc.201336—
+2K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+2K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc.201218—
+2K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+2K121541Jazz SystemImplanet, S.A.201227—
+2K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+2K121250OP Spine SystemOrthoPediatrics Corp.201218—
+2K113044Synthes MirsSynthes Spine2011933
+2K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+3K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+3K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+3K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+3K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K240392JAZZ Spinal SystemImplanet20241—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+3K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+3K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+3K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+3K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…Spinal Simplicity, LLC20223—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+3K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…Spinal Simplicity, LLC20215—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K210549ARx Spinal SystemLife Spine, Inc.20211—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+3K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC20206—
+3K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+3K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+3K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+3K200281The Gecko Spinal SystemOrtho Development Corporation20200—
+3K200097Response BandLoc Spinal FixationOrthoPediatrics Corp.20200—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+3K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+3K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K191575ARx Spinal SystemLife Spine, Inc.201910—
+3K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+3K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+3K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—