510(k) Report

Devices descending from K020699

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+8K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+8K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+8K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+8K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+8K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+8K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+8K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+8K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+8K142499Reline SystemNu Vasive, Incorporated201478—
+8K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+8K133402K2M Modular HooksK2m, Inc.20140—
+8K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+8K132361Everest Spinal SystemK2m, Inc.201334—
+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—
+9K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+9K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+9K241525ExcelsiusXR™Globus Medical, Inc.20250—
+9K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+9K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+9K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+9K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+9K243693NEO Pedicle Screw System™Neo Medical SA20240—
+9K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+9K240160EGPS Navigated InstrumentsAstura Medical20240—
+9K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+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—
+9K231515MySpine Cervical GuidesMedacta International S.A.20230—
+9K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+9K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+9K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+9K231658VEOS Spinal Fixation SystemSpineway20230—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+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—
+9K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+9K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+9K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+9K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+9K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+9K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+9K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+9K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+9K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+9K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+9K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+9K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+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—
+9K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+9K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+9K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+9K201569CUVIS-spineCurexo, Inc.20212—
+9K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+9K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+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—
+9K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+9K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+9K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+9K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+9K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+9K201006K2M Navigation InstrumentsK2m, Inc.20200—
+9K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+9K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+9K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+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—
+9K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+9K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+9K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+9K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+9K191217Jazz PFImplanet, S.A.20190—