510(k) Report

Devices descending from K003836

1,330 later devices reach Synthes Synex Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+5K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+5K203444BEE HA CageNGMedical GmbH20211—
+5K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+5K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+5K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+5K201585Monterey AL Interbody SystemStryker Corporation202044
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+5K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+5K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+5K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+5K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+5K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+5K192906Mecta-C Stand AloneMedacta International S.A.20201—
+5K193521Steerable Plateau TiLife Spine, Inc.20201—
+5K192993Scarlet AL-TSpineart20201—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+5K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K1803473d CageFims Co., Ltd.20190—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+5K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+5K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+5K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+5K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+5K190380nvcNvision Biomedical Technologies, Inc.20193—
+5K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+5K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+5K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+5K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+5K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+5K180909REVEL SpacersGlobus Medical, Inc.201837—
+5K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+5K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+5K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+5K181397DualXInnovasive, Inc.201815—
+5K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K181337Sypher Spacer SystemBiogennix, LLC20180—
+5K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+5K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+5K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+5K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+5K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+5K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+5K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+5K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+5K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+5K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+5K172480icotec Interbody Cage SystemIcotec AG20185—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+5K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+5K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+5K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+5K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+5K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+5K172816TiGer Shark™ SystemChoicespine, LP201859—
+5K171312FortiCore®Nanovis, LLC20183—
+5K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+5K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+5K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+5K172424Velofix™ SA Cervical CageU&I Corporation201751
+5K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+5K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+5K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+5K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+5K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+5K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+5K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—