510(k) Report

Devices descending from K030285

628 later devices reach Modification to TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+10K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+10K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+10K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+10K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+10K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+10K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+10K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+10K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+10K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+10K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+10K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+10K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+10K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+10K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+10K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+10K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+10K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+10K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+10K242042TriALTIS™ Spine SystemMedos International SARL20241—
+10K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+10K233256Robotic Integration InstrumentsDePuy Synthes20240—
+10K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+10K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+10K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+10K233300POWEReam 1/4 DriveStryker Instruments20231—
+10K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—
+10K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+10K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+10K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+10K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+10K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+10K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+10K222789VADER® Pedicle System, G21 CementIcotec AG202352
+10K223294SpineJack® Expansion KitStryker Instruments20221—
+10K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+10K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+10K222698CUVIS-spineCurexo, Inc.20220—
+10K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+10K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+10K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+10K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+10K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+10K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+10K213918DeGen Navigated InstrumentationDegen Medical20220—
+10K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+10K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+10K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+10K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+10K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+10K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+10K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+10K182240PASS LP Spinal SystemMedicrea International SA20182—
+10K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+10K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+10K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+10K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+10K172194Connector SystemOrthofix, Inc.2017162
+10K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+10K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+11K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+11K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+11K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+11K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+11K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+11K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+11K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+11K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+11K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+11K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+11K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+11K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+11K250637VCFix Spinal SystemAmber Implants20250—
+11K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+11K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+11K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+11K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+11K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+11K241846E3D™-C Interbody SystemEvolution Spine20246—
+11K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+11K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+11K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+11K240526POWEReam Xia/SerratoStryker Instruments20240—
+11K232628VADER® Pedicle SystemIcotec AG20241—
+11K232432E3D™-A Interbody SystemEvolution Spine20248—
+11K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+11K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+11K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+11K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+11K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+11K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+11K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+11K200896Solstice CCILife Spine, Inc.20200—
+11K190751Connector SystemOrthofix, Inc.20193—
+11K190376PASS LP Spinal SystemMedicrea International SA201915