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
+8K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+8K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+8K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+8K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+8K240453ReBOSSISOrthorebirth Co., Ltd.202402
+8K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+8K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+8K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+8K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+8K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+8K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+8K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+8K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+8K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+8K223326Axiom PSR SystemRestor3D202301
+8K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+8K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+8K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+8K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+8K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+8K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+8K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+8K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+8K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+8K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+8K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+8K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+8K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+8K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+8K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+8K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+8K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+8K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+8K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+8K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+8K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+8K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+8K201671A-Link ZAcuity Surgical Devices, LLC202125—
+8K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+8K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+8K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+8K201087CORBEL SpacersGlobus Medical, Inc.202036—
+8K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+8K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+8K200312Tryptik TiSpineart20202—
+8K192993Scarlet AL-TSpineart20201—
+8K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+8K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+8K191134IB3D AlifMedicrea International SA20191—
+8K1803473d CageFims Co., Ltd.20190—
+8K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+8K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+8K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+8K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+8K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+8K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+8K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+8K182584Lucent® XPSpinal Elements, Inc.20183—
+8K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+8K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+8K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+8K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+8K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+8K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+8K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+8K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+8K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+9K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+9K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K260810Anteralign LS coverplateTyber Medical, LLC20260—