510(k) Report

Devices descending from K003275

1,705 later devices reach Synthes Synmesh Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+9K193174Keos Lumbar IBFDKeos20190—
+9K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+9K182349Concorde LiftMedos International SARL20190—
+9K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+9K182721Choice Spine Navigation SystemChoicespine, LP20192—
+9K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+9K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+9K181188EVEREST Spinal SystemK2m, Inc.20186—
+9K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+9K173537Concorde Lift™Medos International SARL20181—
+9K171321K2M Navigation InstrumentsK2m201711
+9K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+9K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+9K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+9K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+9K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+9K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+9K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+9K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+9K152651AccuLIF TL and PL CageStryker Corporation201530—
+9K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+9K152304Tritanium PL CageStryker20154481
+9K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+9K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+9K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+9K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+9K130445Vault Alif SystemSpinal USA20139—
+9K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+9K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+9K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+10K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+10K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+10K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+10K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+10K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+10K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+10K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+10K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+10K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+10K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+10K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+10K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+10K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+10K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+10K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+10K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+10K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+10K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+10K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+10K221244CD Horizon™ Spinal SystemMedtronic202220—
+10K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+10K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+10K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+10K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+10K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+10K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+10K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+10K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+10K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+10K201006K2M Navigation InstrumentsK2m, Inc.20200—
+10K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+10K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+10K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+10K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+10K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+10K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+10K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+10K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+10K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+10K172115Navigated Instrument SystemOrthofix, Inc.20184—
+10K162921Navigated Instrument SystemOrthofix, Inc.20175—
+10K163180Hubble IIOrbbo Surgical, LLC20160—
+10K162262Tritanium® PL CageStryker2016132—
+10K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+10K160955Tritanium® PL CageStryker2016178—
+10K160715AccuLIF TL and PL CageStryker Corporation20160—
+10K153400ProLift Expandable SystemLife Spine, Inc.201672—
+10K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+10K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+10K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+10K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—