510(k) Report

Devices descending from K031780

1,326 later devices reach Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+8K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243474MagnetOs MISKuros Biosciences B.V20250—
+8K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K243188Cylox® STSignus Medizintechnik GmbH20250—
+8K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+8K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+8K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+8K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+8K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+8K240453ReBOSSISOrthorebirth Co., Ltd.202402
+8K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+8K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+8K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+8K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+8K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+8K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K230614Cortium™Ulrich Medical USA20230—
+8K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+8K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+8K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+8K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+8K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+8K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+8K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+8K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+8K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+8K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+8K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+8K190488ProLift Expandable SystemLife Spine, Inc.201916—
+8K183064TxTi IBF SystemInnovasis, Inc.2019481
+8K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+8K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+8K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+8K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+8K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+8K182182YUKON OCT Spinal SystemK2m20185—
+8K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+8K172941CASCADIA Interbody SystemK2m201852—
+8K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+8K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+8K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+8K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+8K171704CAPRI Corpectomy Cage SystemK2m201710—
+8K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+8K171425Concorde LiftMedos International SARL201782
+8K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+8K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+8K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+8K162496Foundation 3D InterbodyCorelink, LLC201782—
+8K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+8K162575Z-LINKPC SystemZavation, LLC20173—
+8K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+8K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+8K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+8K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+8K150918PASS OCT Spinal SystemMedicrea International SA201513—
+8K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+8K141284Caspian Spinal SystemK2m, Inc.20140—
+8K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+8K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+8K131833Centurion Poct SystemOrthofix, Inc.20142—