510(k) Report

Devices descending from K080401

840 later devices reach Shell Cage, Wave Cage, Loop Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+6K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+6K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+6K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+6K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+6K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+6K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+6K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+6K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+6K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+6K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+6K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+6K152622Alta ACDF SystemBiomet Spine20160—
+6K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+6K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+7K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260660SABER-C SystemElevation Spine20261—
+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—
+7K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+7K250769Dakota LP SystemPrecision Spine, Inc.20250—
+7K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, 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—
+7K250540SABER-C SystemElevation Spine20252—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+7K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+7K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+7K243474MagnetOs MISKuros Biosciences B.V20250—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+7K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+7K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.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—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+7K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+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—
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K240453ReBOSSISOrthorebirth Co., Ltd.202402
+7K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+7K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+7K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+7K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K221578Hexanium ACIFSpinevision, S.A.S.20224—
+7K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+7K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+7K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+7K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+7K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+7K210573Velofix SA Cervical CageU&I Corporation20211—
+7K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+7K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+7K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+7K201671A-Link ZAcuity Surgical Devices, LLC202125—
+7K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+7K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+7K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+7K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+7K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—