510(k) Report

Devices descending from K070082

641 later devices reach XY Cor Spinal Implant for Minimal Invasive Spinal Surgery through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+6K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+6K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+6K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+6K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+6K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+6K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+6K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+6K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+6K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+6K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+6K162496Foundation 3D InterbodyCorelink, LLC201782—
+6K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+6K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+6K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+6K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+6K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+6K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+6K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+6K143479Bluefin Interbody SystemTides Medical20152—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+7K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+7K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+7K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+7K250556Porous Biologic ScaffoldVentris Medical20250—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+7K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+7K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+7K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+7K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+7K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+7K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+7K240442MagnetOs PuttyKuros Biosciences B.V20243—
+7K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+7K240458Synthetic Bone PuttyVentris Medical20242—
+7K240459Cerament Bone Void FillerBonesupport AB20240—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K232347MagnetOs GranulesKuros Biosciences B.V20242—
+7K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+7K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+7K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+7K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+7K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+7K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+7K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+7K232315Catalyst Bone Void FillerOssdsign AB20237—
+7K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+7K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+7K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K230329F3D Interbody SystemCorelink, LLC20230—
+7K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+7K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+7K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+7K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+7K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+7K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—