510(k) Report

Devices descending from K963655

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+5K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+5K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+5K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+5K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+5K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+5K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+5K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+5K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+5K211740DualXAmplify Surgical, Inc.20211—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+5K210306GII Spinal Fixation SystemColigne AG20210—
+5K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+5K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K203816DeGen Navigated InstrumentationDegen Medical20211—
+5K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+5K210472SPINEART Navigation Instrument SystemSpineart20215—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+5K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K201648Sterispine™ PSSafe Orthopaedics202011
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+5K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+5K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+5K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+5K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+5K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—