510(k) Report

Devices descending from K062807

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+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—
+9K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+9K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+9K201006K2M Navigation InstrumentsK2m, Inc.20200—
+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—
+9K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+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—
+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
+9K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+9K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+9K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+9K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+9K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+9K181188EVEREST Spinal SystemK2m, Inc.20186—
+9K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+9K180324Patriot Spinal Fixation SystemValorus Spine20180—
+9K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+9K180153X-spine Cortical Bone Screw SystemX-Spine Systems, 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—
+9K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+9K171881JAZZ Passer BandImplanet, S.A.20170—
+9K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+9K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+9K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+9K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+9K170647Connector SystemOrthofix, Inc.201718—
+9K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+9K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+9K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+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—
+9K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+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—
+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—
+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—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+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—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+10K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+10K242042TriALTIS™ Spine SystemMedos International SARL20241—
+10K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+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—
+10K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+10K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+10K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+10K222789VADER® Pedicle System, G21 CementIcotec AG202352