510(k) Report

Devices descending from K070229

598 later devices reach Range Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K240392JAZZ Spinal SystemImplanet20241—
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K232628VADER® Pedicle SystemIcotec AG20241—
+6K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+6K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+6K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+6K221244CD Horizon™ Spinal SystemMedtronic202220—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+6K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+6K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+6K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K203452Nano FortiFix® SystemNanovis, LLC20200—
+6K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+6K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+6K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+6K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+6K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+6K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+6K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+6K190751Connector SystemOrthofix, Inc.20193—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+6K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+6K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+6K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+6K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+6K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+6K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+6K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+6K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+6K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+6K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+6K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+6K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+6K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K162921Navigated Instrument SystemOrthofix, Inc.20175—
+6K162764Jazz Frame SystemImplanet, S.A.20176—
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K161842Overwatch Spine SystemAmendia, Inc.201661
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+6K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+6K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+6K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+6K153404Zavation Spinal SystemZavation, LLC20161—
+6K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+6K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+6K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+6K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+6K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+6K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+6K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+6K141850Flospine Pedicle Screw SystemFlospine20140—
+6K133366Orthros Posterior Stabilization SystemCamber Spine20142—