510(k) Report

Devices descending from K082801

643 later devices reach Phantom Plus Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+6K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+6K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+6K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+6K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+6K210573Velofix SA Cervical CageU&I Corporation20211—
+6K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+6K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K201671A-Link ZAcuity Surgical Devices, LLC202125—
+6K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+6K200919Idys ALIF 3DTiClariance20210—
+6K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+6K202032Idys LLIF 3DTiClariance, Sas20210—
+6K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+6K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+6K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+6K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+6K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+6K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+6K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+6K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+6K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+6K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+6K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+6K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+6K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+6K192897icotec Cervical CageIcotec AG20201—
+6K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+6K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+6K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+6K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+6K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+6K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+6K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+6K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+6K172816TiGer Shark™ SystemChoicespine, LP201859—
+6K172419Velofix™ TLIF CageU&I Corporation20172—
+6K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+6K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+6K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+6K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+6K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+6K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—
+7K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K263049SABER-C SystemElevation Spine20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+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—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+7K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+7K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+7K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+7K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+7K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+7K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+7K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—