510(k) Report

Devices descending from K001255

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K241258Ingenix Spinal SystemIngenium Spine20240—
+8K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+8K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+8K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+8K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+8K223273ASTRA Spine SystemSpinecraft, LLC20228—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+8K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+8K222698CUVIS-spineCurexo, Inc.20220—
+8K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+8K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+8K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+8K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+8K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+8K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+8K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+8K200896Solstice CCILife Spine, Inc.20200—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+8K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+8K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+8K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+8K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+8K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+8K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+8K182470Plateau Spacer SystemLife Spine20180—
+8K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+8K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+8K180433Ennovate®Aesculap Implant Systems, LLC201811
+8K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+8K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+8K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+8K172194Connector SystemOrthofix, Inc.2017162
+8K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+8K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+8K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+8K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+8K161149PASS OCT Spinal SystemMedicrea International SA20160—
+8K160756PASS OCT Spinal SystemMedicrea International SA20160—
+8K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+8K153169PASS OCT Patient Specific RodsMedicrea International20164—
+8K152211PCT SystemCentinel Spine, Inc.20150—
+8K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+8K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+9K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+9K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+9K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+9K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+9K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+9K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+9K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+9K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+9K231658VEOS Spinal Fixation SystemSpineway20230—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+9K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+9K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+9K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+9K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+9K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+9K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+9K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+9K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+9K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+9K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+9K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+9K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+9K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+9K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+9K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+9K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+9K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+9K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+9K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—