510(k) Report

Devices descending from K101310

480 later devices reach VU Apod Intervertebral Body Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+6K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+6K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+6K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+6K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K250556Porous Biologic ScaffoldVentris Medical20250—
+6K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+6K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+6K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+6K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+6K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+6K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+6K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+6K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+6K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+6K240699SCARLET® AC-TiSpineart SA20240—
+6K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+6K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+6K240442MagnetOs PuttyKuros Biosciences B.V20243—
+6K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+6K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K240458Synthetic Bone PuttyVentris Medical20242—
+6K240459Cerament Bone Void FillerBonesupport AB20240—
+6K232347MagnetOs GranulesKuros Biosciences B.V20242—
+6K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+6K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+6K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+6K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+6K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+6K232315Catalyst Bone Void FillerOssdsign AB20237—
+6K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+6K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+6K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+6K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+6K230583Tryptik TiSpineart SA20231—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+6K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+6K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+6K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+6K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+6K213417Ghost Spacer SystemLife Spine, Inc.20220—
+6K222561AlignAcuity Surgical Devices, LLC202214—
+6K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+6K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+6K220610SOLO-LAurora Spine, Inc.20220—
+6K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+6K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+6K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+6K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+6K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+6K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+6K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+6K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+6K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+6K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K192897icotec Cervical CageIcotec AG20201—
+6K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+6K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+6K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+6K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+6K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+7K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—