510(k) Report

Devices descending from K100043

744 later devices reach Coroent XLR Standalone System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+3K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+3K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+3K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+3K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+3K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+3K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+3K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+3K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+3K132738Cogent Med-LifCogent Spine, LLC201413—
+4K263049SABER-C SystemElevation Spine20260—
+4K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+4K261049Scala® TLSpineart SA20260—
+4K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+4K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+4K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K243474MagnetOs MISKuros Biosciences B.V20250—
+4K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+4K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+4K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+4K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+4K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+4K242589Scarlet® AL-TSpineart SA20240—
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+4K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+4K240453ReBOSSISOrthorebirth Co., Ltd.202402
+4K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+4K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+4K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+4K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+4K223326Axiom PSR SystemRestor3D202301
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+4K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+4K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+4K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+4K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+4K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+4K213417Ghost Spacer SystemLife Spine, Inc.20220—
+4K222561AlignAcuity Surgical Devices, LLC202214—
+4K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+4K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K220610SOLO-LAurora Spine, Inc.20220—
+4K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—