510(k) Report

Devices descending from K132328

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+1K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+1K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+1K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+1K142360Everest Spinal SystemK2m, Inc.201522—
+1K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+1K141147Range Spinal SystemK2m, Inc.20141—
+1K140529Everest Spinal SystemK2m, LLC201431—
+1K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+2K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+2K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+2K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+2K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+2K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+2K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+2K173508Everest Spinal SystemK2m20189—
+2K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+2K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K151727Everest Spinal SystemK2m, Inc.201511—
+2K151216Everest Spinal SystemK2m, Inc.201511—
+2K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+2K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+2K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+2K142381Xia 3 Spinal SystemStryker Corp.201483—
+2K133402K2M Modular HooksK2m, Inc.20140—
+2K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+3K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+3K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K210637CD Horizon™ Spinal SystemMedtronic202134—
+3K210549ARx Spinal SystemLife Spine, Inc.20211—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+3K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+3K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+3K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+3K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+3K200070ARx Spinal SystemLife Spine, Inc.20209—
+3K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+3K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+3K191575ARx Spinal SystemLife Spine, Inc.201910—
+3K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+3K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K173126Arisstos™ Spinal SystemIngenium Spine20171—
+3K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+3K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+3K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+3K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K253249TriALTIS™ Spine SystemMedos International SARL20251—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K241258Ingenix Spinal SystemIngenium Spine20240—
+4K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233300POWEReam 1/4 DriveStryker Instruments20231—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—