510(k) Report

Devices descending from K071833

963 later devices reach Mosaic Devices through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+6K181048Neo Cage System TMNeo Medical SA20191—
+6K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+6K182470Plateau Spacer SystemLife Spine20180—
+6K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+6K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+6K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+6K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+6K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+6K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+6K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+6K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+6K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+6K172816TiGer Shark™ SystemChoicespine, LP201859—
+6K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+6K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+6K172419Velofix™ TLIF CageU&I Corporation20172—
+6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+6K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+6K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+6K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+6K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+6K162496Foundation 3D InterbodyCorelink, LLC201782—
+6K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+6K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+6K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+6K162262Tritanium® PL CageStryker2016132—
+6K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+6K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+6K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+6K160955Tritanium® PL CageStryker2016178—
+6K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+6K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+6K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+6K152651AccuLIF TL and PL CageStryker Corporation201530—
+6K143479Bluefin Interbody SystemTides Medical20152—
+6K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+6K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+6K132738Cogent Med-LifCogent Spine, LLC201413—
+7K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261430TruLift Expandable SystemLife Spine, Inc.20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+7K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+7K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+7K250560BEE HANGMedical GmbH20250—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+7K243474MagnetOs MISKuros Biosciences B.V20250—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+7K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+7K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+7K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+7K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+7K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+7K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+7K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+7K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K240453ReBOSSISOrthorebirth Co., Ltd.202402