510(k) Report

Devices descending from K001255

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K240392JAZZ Spinal SystemImplanet20241—
+5K233300POWEReam 1/4 DriveStryker Instruments20231—
+5K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+5K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+5K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+5K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+5K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+5K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+5K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+5K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+5K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+5K221244CD Horizon™ Spinal SystemMedtronic202220—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+5K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+5K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+5K210637CD Horizon™ Spinal SystemMedtronic202134—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+5K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+5K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+5K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+5K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+5K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K183381Navigation Enabled InstrumentsStryker20191—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+5K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+5K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K173508Everest Spinal SystemK2m20189—
+5K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+5K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+5K171321K2M Navigation InstrumentsK2m201711
+5K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K161028K2M Growing Spine SystemK2m, Inc.20163—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K141850Flospine Pedicle Screw SystemFlospine20140—
+5K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+5K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+5K141147Range Spinal SystemK2m, Inc.20141—
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K132757Everest Spinal SystemK2m, Inc.201341—
+5K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+5K131784Range Spinal SystemK2m, Inc.201334—
+5K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+5K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811