510(k) Report

Devices descending from K000319

700 later devices reach Ebi Xfix DFS System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+6K192915GMA 2.0 Pedicle Screw SystemGrafton Medical Alliance20190—
+6K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+6K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+6K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+6K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+6K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+6K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+6K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+6K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K173508Everest Spinal SystemK2m20189—
+6K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+6K171838TiLock2 Spinal SystemGenesys Spine20174—
+6K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+6K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+6K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+6K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+6K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+6K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+6K161369EVEREST Spinal SystemK2m, Incorporated20169—
+6K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+6K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+6K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+6K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+6K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+6K151974Polaris Spinal SystemBiomet Spine201516—
+6K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+6K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+6K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+6K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+6K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+6K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+6K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+6K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+6K150507Santis Pedicle Screw SystemLanterna Medical Technologies20150—
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K140359Maximis Spinal Fixation SystemValorem Surgical20150144
+6K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+6K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+6K142499Reline SystemNu Vasive, Incorporated201478—
+6K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+6K133402K2M Modular HooksK2m, Inc.20140—
+6K140529Everest Spinal SystemK2m, LLC201431—
+6K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+6K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+6K132361Everest Spinal SystemK2m, Inc.201334—
+6K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+6K123552Instinct Java SystemZimmer Spine201301
+6K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+6K112493Pass LP Spinal SystemMedicrea International20111—
+6K110497Pass LP Spinal SystemMedicrea International20111331
+6K111502Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201188—
+7K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K252437JAZZ Spinal SystemImplanet20250—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+7K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+7K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—