510(k) Report

Devices descending from K052187

780 later devices reach Modification to: CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243249TriALTIS™ Spine SystemMedos International SARL20250—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243693NEO Pedicle Screw System™Neo Medical SA20240—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233684TriALTIS™ Spine SystemMedos International SARL20234—
+6K231515MySpine Cervical GuidesMedacta International S.A.20230—
+6K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K231658VEOS Spinal Fixation SystemSpineway20230—
+6K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+6K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+6K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+6K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+6K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+6K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+6K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+6K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+6K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K211740DualXAmplify Surgical, Inc.20211—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+6K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+6K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+6K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+6K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+6K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+6K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+6K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+6K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+6K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+6K200896Solstice CCILife Spine, Inc.20200—
+6K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+6K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+6K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+6K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+6K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—