510(k) Report

Devices descending from K093669

744 later devices reach Sec Ibf Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K250540SABER-C SystemElevation Spine20252—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+6K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K243474MagnetOs MISKuros Biosciences B.V20250—
+6K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+6K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+6K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+6K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+6K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+6K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+6K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+6K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+6K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+6K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+6K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+6K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+6K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+6K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+6K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+6K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+6K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+6K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+6K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+6K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+6K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+6K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+6K201671A-Link ZAcuity Surgical Devices, LLC202125—
+6K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201087CORBEL SpacersGlobus Medical, Inc.202036—
+6K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+6K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+6K191796Neo Cage SystemNeo Medical SA20190—
+6K181048Neo Cage System TMNeo Medical SA20191—
+6K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+6K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+6K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+6K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+6K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+6K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+6K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+6K172419Velofix™ TLIF CageU&I Corporation20172—
+6K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+6K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+6K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+6K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+6K162262Tritanium® PL CageStryker2016132—
+6K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+6K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+6K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+6K160955Tritanium® PL CageStryker2016178—
+6K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+6K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+6K160125Cascadia Interbody SystemK2m2016315—
+6K152651AccuLIF TL and PL CageStryker Corporation201530—
+7K263049SABER-C SystemElevation Spine20260—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—