510(k) Report

Devices descending from K062083

1,252 later devices reach Synfix -LR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+6K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+6K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+6K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+6K212930LumiVy Lumbar IBF SystemVy Spine, LLC20226—
+6K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+6K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+6K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+6K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+6K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+6K211413BEE PLIF CageNGMedical GmbH20211—
+6K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+6K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+6K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+6K211306LabyrinthZavation Medical Products, LLC20213—
+6K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+6K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+6K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+6K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+6K200429BEE CagesNGMedical GmbH202111—
+6K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+6K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+6K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+6K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+6K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+6K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+6K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+6K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+6K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+6K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+6K190721LongBow TiLife Spine, Inc.20190—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+6K190885Elevation Spine Saber-C SystemElevation Spine201925—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K190488ProLift Expandable SystemLife Spine, Inc.201916—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+6K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+6K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+6K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+6K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+6K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+6K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+6K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+6K180909REVEL SpacersGlobus Medical, Inc.201837—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K181397DualXInnovasive, Inc.201815—
+6K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+6K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+6K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+6K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+6K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+6K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+6K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+6K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+6K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+6K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+6K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC20189—
+6K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+6K173508Everest Spinal SystemK2m20189—
+6K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+6K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+6K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+6K172419Velofix™ TLIF CageU&I Corporation20172—
+6K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+6K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+6K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+6K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+6K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+6K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+6K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+6K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+6K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—