510(k) Report

Devices descending from K051027

908 later devices reach Stalif TT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+5K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+5K182470Plateau Spacer SystemLife Spine20180—
+5K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+5K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+5K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+5K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+5K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+5K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+5K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+5K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+5K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+5K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+5K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+5K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+5K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+5K172816TiGer Shark™ SystemChoicespine, LP201859—
+5K171312FortiCore®Nanovis, LLC20183—
+5K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+5K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+5K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+5K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+5K172065Scarlet AC-TSpineart20172—
+5K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+5K171140Matrixx SystemNexxt Spine, LLC2017145—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+5K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+5K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+5K162496Foundation 3D InterbodyCorelink, LLC201782—
+5K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+5K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+5K170055CAPRI Corpectomy Cage SystemK2m201711—
+5K163364MOJAVE Expandable Interbody SystemK2m201725—
+5K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+5K162262Tritanium® PL CageStryker2016132—
+5K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+5K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+5K162264Cascadia Interbody SystemK2m, Inc.2016169—
+5K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+5K160955Tritanium® PL CageStryker2016178—
+5K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+5K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+5K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+5K152651AccuLIF TL and PL CageStryker Corporation201530—
+5K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+5K143479Bluefin Interbody SystemTides Medical20152—
+5K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+5K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+5K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+5K132738Cogent Med-LifCogent Spine, LLC201413—
+6K263049SABER-C SystemElevation Spine20260—
+6K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K261430TruLift Expandable SystemLife Spine, Inc.20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+6K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+6K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+6K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K252742Navigated InstrumentsTyber Medical, LLC20251—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+6K243474MagnetOs MISKuros Biosciences B.V20250—
+6K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+6K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+6K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—