510(k) Report

Devices descending from K063670

821 later devices reach Modifications to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+6K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+7K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K253249TriALTIS™ Spine SystemMedos International SARL20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K243693NEO Pedicle Screw System™Neo Medical SA20240—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K240160EGPS Navigated InstrumentsAstura Medical20240—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+7K233300POWEReam 1/4 DriveStryker Instruments20231—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K231515MySpine Cervical GuidesMedacta International S.A.20230—
+7K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+7K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+7K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+7K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+7K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+7K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+7K222789VADER® Pedicle System, G21 CementIcotec AG202352
+7K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+7K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+7K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+7K201569CUVIS-spineCurexo, Inc.20212—
+7K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+7K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+7K201585Monterey AL Interbody SystemStryker Corporation202044
+7K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+7K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+7K200896Solstice CCILife Spine, Inc.20200—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+7K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+7K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+7K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+7K191217Jazz PFImplanet, S.A.20190—
+7K191045Salvo™ Spine SystemSpine Wave, Inc.20195—