510(k) Report

Devices descending from K052096

790 later devices reach Nubic Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+8K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+8K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+8K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+8K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+8K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+8K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+9K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+9K263049SABER-C SystemElevation Spine20260—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+9K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K253331PressON Spinal Fixation SystemNexus Spine20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+9K241525ExcelsiusXR™Globus Medical, Inc.20250—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243188Cylox® STSignus Medizintechnik GmbH20250—
+9K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+9K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+9K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+9K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+9K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+9K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+9K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+9K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+9K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+9K240453ReBOSSISOrthorebirth Co., Ltd.202402
+9K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+9K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+9K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+9K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+9K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+9K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+9K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+9K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+9K213417Ghost Spacer SystemLife Spine, Inc.20220—
+9K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+9K222561AlignAcuity Surgical Devices, LLC202214—
+9K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K220610SOLO-LAurora Spine, Inc.20220—
+9K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+9K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+9K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+9K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+9K211740DualXAmplify Surgical, Inc.20211—
+9K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+9K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+9K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+9K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+9K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+9K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+9K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+9K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+9K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+9K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+9K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—