510(k) Report

Devices descending from K060615

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+7K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+7K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K253249TriALTIS™ Spine SystemMedos International SARL20251—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+8K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K243693NEO Pedicle Screw System™Neo Medical SA20240—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K240160EGPS Navigated InstrumentsAstura Medical20240—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+8K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+8K233300POWEReam 1/4 DriveStryker Instruments20231—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K231515MySpine Cervical GuidesMedacta International S.A.20230—
+8K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+8K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+8K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+8K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+8K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K223558CUVIS-spineCurexo, Inc.20230—
+8K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+8K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+8K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+8K222789VADER® Pedicle System, G21 CementIcotec AG202352
+8K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+8K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+8K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+8K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+8K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+8K201569CUVIS-spineCurexo, Inc.20212—
+8K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+8K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+8K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+8K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+8K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+8K201585Monterey AL Interbody SystemStryker Corporation202044
+8K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+8K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+8K200896Solstice CCILife Spine, Inc.20200—
+8K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+8K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+8K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+8K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+8K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+8K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+8K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+8K191217Jazz PFImplanet, S.A.20190—