510(k) Report

Devices descending from K000319

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200822—
+4K071074Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20080—
+4K081296Preference Pedicle Screw SystemUs Spine20083—
+4K080876DVX Spine SystemBk Meditech, Co., Ltd.20081—
+4K080767Conquest Spinal SystemLife Spine200821—
+4K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+4K073240PSS SystemSpinal USA200836—
+4K080518Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology2008174—
+4K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC20080—
+4K080026Quantum-Mis Cannulated SystemPioneer Surgical Technology200812—
+4K072685Ngarde SystemN Spine, Inc.200709
+4K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200749—
+4K062912Scient'x Spinal SystemScient'X200736—
+4K051286Zodiac Spinal Fixation SystemAlphatec/Nexmed2005176—
+5K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+5K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+5K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+5K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K241258Ingenix Spinal SystemIngenium Spine20240—
+5K240350AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd.20240—
+5K2326074CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle…Solco Biomedical Copany India Private Limited20240—
+5K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+5K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+5K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+5K222789VADER® Pedicle System, G21 CementIcotec AG202352
+5K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+5K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+5K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+5K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+5K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+5K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+5K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+5K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+5K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+5K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+5K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+5K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+5K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+5K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+5K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+5K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+5K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+5K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+5K161028K2M Growing Spine SystemK2m, Inc.20163—
+5K152920Savannah-T® Pedicle Screw SystemAmendia, Inc.201601
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+5K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+5K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+5K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+5K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+5K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+5K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+5K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+5K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+5K141397Sure-Lok C Extended Tab Pedicle Screw SystemPrecision Spine, Inc.20140—
+5K141147Range Spinal SystemK2m, Inc.20141—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+5K140219Picasso II Mis Spinal SystemAccel Spine20141—