510(k) Report

Devices descending from K022778

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+9K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+9K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+9K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K243249TriALTIS™ Spine SystemMedos International SARL20250—
+9K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+9K243693NEO Pedicle Screw System™Neo Medical SA20240—
+9K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+9K240160EGPS Navigated InstrumentsAstura Medical20240—
+9K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+9K241258Ingenix Spinal SystemIngenium Spine20240—
+9K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+9K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+9K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K233684TriALTIS™ Spine SystemMedos International SARL20234—
+9K231515MySpine Cervical GuidesMedacta International S.A.20230—
+9K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+9K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+9K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+9K223558CUVIS-spineCurexo, Inc.20230—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+9K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+9K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+9K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+9K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+9K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+9K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+9K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+9K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+9K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+9K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+9K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+9K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+9K201569CUVIS-spineCurexo, Inc.20212—
+9K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+9K203816DeGen Navigated InstrumentationDegen Medical20211—
+9K210472SPINEART Navigation Instrument SystemSpineart20215—
+9K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+9K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+9K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+9K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+9K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+9K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+9K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+9K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+9K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+9K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+9K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+9K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+9K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+9K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+9K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+9K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+9K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+9K191217Jazz PFImplanet, S.A.20190—
+9K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+9K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+9K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+9K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+9K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+9K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+9K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+9K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+9K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+9K172469TiLock Modular Spinal SystemGenesys Spine20170—
+9K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+9K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+9K171881JAZZ Passer BandImplanet, S.A.20170—
+9K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+9K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+9K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+9K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+9K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+9K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+9K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+9K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+9K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+10K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+10K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+10K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+10K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+10K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+10K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—