510(k) Report

Devices descending from K001864

733 later devices reach Synthes Cervifix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K141147Range Spinal SystemK2m, Inc.20141—
+6K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+6K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+6K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+6K131784Range Spinal SystemK2m, Inc.201334—
+6K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+6K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+6K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+6K121728Tiger Spine SystemCorelink, LLC201250—
+6K121172Reform Pedicle Screw SystemSpinal USA201233—
+6K121020Viper SystemDepuy Spine, Inc.201294—
+6K120696Tiger Spine SystemCorelink, LLC201241—
+6K080767Conquest Spinal SystemLife Spine200821—
+7K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+7K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+7K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K253249TriALTIS™ Spine SystemMedos International SARL20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+7K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+7K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+7K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+7K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+7K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+7K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+7K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+7K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+7K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+7K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K203205Navigated Spine InstrumentsStryker Spine20218—
+7K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+7K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+7K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+7K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+7K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+7K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+7K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+7K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+7K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+7K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+7K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+7K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+7K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+7K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K171582NEO Pedicle Screw System™Neo Medical SA20170—
+7K171321K2M Navigation InstrumentsK2m201711
+7K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+7K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+7K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+7K161028K2M Growing Spine SystemK2m, Inc.20163—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+7K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K151755OASYS (r) SystemStryker Corporation201533—
+7K150417Astra Spine SystemSpinecraft, LLC201521—
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—