510(k) Report

Devices descending from K050079

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+8K172469TiLock Modular Spinal SystemGenesys Spine20170—
+8K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+8K171881JAZZ Passer BandImplanet, S.A.20170—
+8K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+8K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+8K170647Connector SystemOrthofix, Inc.201718—
+8K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+8K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+8K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+8K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+9K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+9K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K240699SCARLET® AC-TiSpineart SA20240—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+9K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+9K233366SYMPHONY OCT SystemMedos International SARL20230—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+9K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K223326Axiom PSR SystemRestor3D202301
+9K222789VADER® Pedicle System, G21 CementIcotec AG202352
+9K223294SpineJack® Expansion KitStryker Instruments20221—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+9K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+9K222698CUVIS-spineCurexo, Inc.20220—
+9K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+9K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+9K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+9K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+9K182470Plateau Spacer SystemLife Spine20180—
+9K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+9K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+9K172194Connector SystemOrthofix, Inc.2017162
+9K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+10K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+10K250637VCFix Spinal SystemAmber Implants20250—
+10K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+10K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+10K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+10K232628VADER® Pedicle SystemIcotec AG20241—
+10K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+10K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+10K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+10K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+10K190751Connector SystemOrthofix, Inc.20193—
+10K182182YUKON OCT Spinal SystemK2m20185—
+10K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+11K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+11K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+11K193129Yukon OCT Spinal SystemK2m, Inc.202001