510(k) Report

Devices descending from K003275

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+6K210573Velofix SA Cervical CageU&I Corporation20211—
+6K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+6K212562Idys-C ZP 3DTiClariance, SA20211—
+6K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+6K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+6K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+6K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+6K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+6K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+6K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+6K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+6K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+6K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+6K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+6K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+6K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+6K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+6K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+6K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+6K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+6K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+6K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+6K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+6K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+6K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+6K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+6K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+6K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+6K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+6K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+6K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+6K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+6K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+6K192993Scarlet AL-TSpineart20201—
+6K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+6K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+6K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+6K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+6K190721LongBow TiLife Spine, Inc.20190—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K1803473d CageFims Co., Ltd.20190—
+6K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+6K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+6K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+6K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+6K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+6K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+6K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+6K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+6K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+6K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+6K190380nvcNvision Biomedical Technologies, Inc.20193—
+6K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+6K183092Kuros TLIF CageKuros Biosciences B.V20190—
+6K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+6K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+6K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+6K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+6K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+6K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+6K181899Roccia® PlifSilony Medical GmbH20180—
+6K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+6K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+6K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+6K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+6K181397DualXInnovasive, Inc.201815—
+6K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+6K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+6K181337Sypher Spacer SystemBiogennix, LLC20180—
+6K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+6K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+6K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+6K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+6K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+6K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+6K180695FBC 921 (Alif)Fbc Device Aps20180—
+6K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+6K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+6K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+6K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+6K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+6K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+6K172480icotec Interbody Cage SystemIcotec AG20185—
+6K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+6K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+6K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—