510(k) Report

Devices descending from K041862

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+7K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+7K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+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—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+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—
+7K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+7K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+7K201585Monterey AL Interbody SystemStryker Corporation202044
+7K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+7K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+7K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+7K200896Solstice CCILife Spine, Inc.20200—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+7K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K191217Jazz PFImplanet, S.A.20190—
+7K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+7K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+7K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+7K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+7K181188EVEREST Spinal SystemK2m, Inc.20186—
+7K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+7K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+7K171881JAZZ Passer BandImplanet, S.A.20170—
+7K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+7K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+7K170647Connector SystemOrthofix, Inc.201718—
+7K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+7K162575Z-LINKPC SystemZavation, LLC20173—
+7K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+7K150918PASS OCT Spinal SystemMedicrea International SA201513—
+7K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+7K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+7K141284Caspian Spinal SystemK2m, Inc.20140—
+7K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+7K131833Centurion Poct SystemOrthofix, Inc.20142—
+7K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+7K120998Solstice Cross ConnectorLife Spine20121—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+8K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+8K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+8K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—