510(k) Report

Devices descending from K982990

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K232628VADER® Pedicle SystemIcotec AG20241—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K231658VEOS Spinal Fixation SystemSpineway20230—
+8K231479TriALTIS Spine SystemMedos International SARL20238—
+8K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+8K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+8K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+8K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+8K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+8K221745Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20220—
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+8K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+8K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+8K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+8K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+8K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+8K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+8K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+8K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+8K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+8K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+8K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+8K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+8K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+8K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+8K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+8K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+8K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+8K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+8K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+8K190751Connector SystemOrthofix, Inc.20193—
+8K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+8K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+8K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+8K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+8K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+8K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+8K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+8K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+8K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+8K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+8K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+8K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+8K173126Arisstos™ Spinal SystemIngenium Spine20171—
+8K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+8K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+8K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+8K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+8K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+8K162764Jazz Frame SystemImplanet, S.A.20176—
+8K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+8K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+8K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+8K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+8K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+8K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+8K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+8K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+8K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+8K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+8K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+8K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+8K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+8K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+8K142499Reline SystemNu Vasive, Incorporated201478—
+8K142381Xia 3 Spinal SystemStryker Corp.201483—
+8K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+8K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+9K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+9K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K253249TriALTIS™ Spine SystemMedos International SARL20251—
+9K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+9K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K243249TriALTIS™ Spine SystemMedos International SARL20250—
+9K243693NEO Pedicle Screw System™Neo Medical SA20240—
+9K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+9K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+9K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+9K241258Ingenix Spinal SystemIngenium Spine20240—
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K233684TriALTIS™ Spine SystemMedos International SARL20234—
+9K231515MySpine Cervical GuidesMedacta International S.A.20230—
+9K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+9K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+9K231483MySpine Unilateral GuidesMedacta International S.A.20230—