510(k) Report

Devices descending from K000319

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K133369Tiger Spine SystemCorelink, LLC201429—
+5K133063Santis Pedicle Screw SystemLanterna Medical Technologies20142—
+5K132757Everest Spinal SystemK2m, Inc.201341—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+5K131784Range Spinal SystemK2m, Inc.201334—
+5K132365Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine201322
+5K131522Core Pedicle Screw SystemCore-Nexus20130—
+5K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+5K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+5K122877Range Spinal System, Small StatureK2m, Inc.201334—
+5K130330Range Spinal SystemK2m, Inc.201336—
+5K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+5K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K120538Palls M Spinal SystemKorea Bone Bank Co., Ltd.20121—
+5K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+5K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+5K111362Rexious Spinal Fixation SystemDio Medical Co., Ltd.201111—
+5K110692Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201189—
+5K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+5K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+5K100297Pass LP Spinal SystemMedicrea Technologies2010136—
+5K090320Conquest Spinal SystemLife Spine20092—
+5K090424DVX Spine SystemBk Meditech, Co., Ltd.20090—
+5K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+5K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+6K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240392JAZZ Spinal SystemImplanet20241—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+6K232628VADER® Pedicle SystemIcotec AG20241—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K231515MySpine Cervical GuidesMedacta International S.A.20230—
+6K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+6K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+6K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+6K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+6K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+6K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+6K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+6K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+6K193219G Surgical Marksman SystemG Surgical, LLC20191—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—