510(k) Report

Devices descending from K982990

776 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+6K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222698CUVIS-spineCurexo, Inc.20220—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K221244CD Horizon™ Spinal SystemMedtronic202220—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+6K210306GII Spinal Fixation SystemColigne AG20210—
+6K210637CD Horizon™ Spinal SystemMedtronic202134—
+6K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+6K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+6K203452Nano FortiFix® SystemNanovis, LLC20200—
+6K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+6K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+6K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+6K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+6K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+6K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+6K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+6K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+6K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K182182YUKON OCT Spinal SystemK2m20185—
+6K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+6K182240PASS LP Spinal SystemMedicrea International SA20182—
+6K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+6K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+6K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+6K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+6K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+6K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+6K170647Connector SystemOrthofix, Inc.201718—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+6K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+6K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K161842Overwatch Spine SystemAmendia, Inc.201661
+6K151977icotec Pedicle SystemIcotec AG201630—
+6K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+6K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+6K151974Polaris Spinal SystemBiomet Spine201516—
+6K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+6K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—