510(k) Report

Devices descending from K081080

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+7K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+7K201569CUVIS-spineCurexo, Inc.20212—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+7K203816DeGen Navigated InstrumentationDegen Medical20211—
+7K210472SPINEART Navigation Instrument SystemSpineart20215—
+7K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+7K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+7K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+7K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+7K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+7K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+7K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+7K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+7K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+7K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+7K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K191217Jazz PFImplanet, S.A.20190—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+7K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+7K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+7K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+7K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+7K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+7K181188EVEREST Spinal SystemK2m, Inc.20186—
+7K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+7K180324Patriot Spinal Fixation SystemValorus Spine20180—
+7K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+7K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+7K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K172469TiLock Modular Spinal SystemGenesys Spine20170—
+7K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+7K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+7K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+7K171881JAZZ Passer BandImplanet, S.A.20170—
+7K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+7K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+7K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+7K170647Connector SystemOrthofix, Inc.201718—
+7K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+7K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+7K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+7K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+7K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+7K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+7K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+7K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+7K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+8K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+8K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+8K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—