510(k) Report

Devices descending from K030601

1,151 later devices reach Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K193258ProLift Expandable SystemLife Spine, Inc.20203—
+9K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+9K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+9K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+9K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+9K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+9K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+9K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+9K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+9K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+9K190680Favo S-TlifSilony Medical GmbH20190—
+9K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+9K183064TxTi IBF SystemInnovasis, Inc.2019481
+9K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+9K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+9K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+9K183092Kuros TLIF CageKuros Biosciences B.V20190—
+9K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+9K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+9K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+9K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+9K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+9K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+9K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+9K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+9K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+9K182182YUKON OCT Spinal SystemK2m20185—
+9K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+9K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+9K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+9K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+9K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+9K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+9K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+9K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+9K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+9K172941CASCADIA Interbody SystemK2m201852—
+9K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+9K172009Cascadia Interbody SystemK2m, Inc.2017433
+9K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+9K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+9K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+9K171704CAPRI Corpectomy Cage SystemK2m201710—
+9K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+9K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+9K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+9K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+9K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+9K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+9K162575Z-LINKPC SystemZavation, LLC20173—
+9K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+9K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+9K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+9K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+9K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+9K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+9K150918PASS OCT Spinal SystemMedicrea International SA201513—
+9K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+9K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+9K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+9K141284Caspian Spinal SystemK2m, Inc.20140—
+9K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+9K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+9K131833Centurion Poct SystemOrthofix, Inc.20142—
+9K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+9K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+9K120998Solstice Cross ConnectorLife Spine20121—
+10K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+10K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+10K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+10K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K261279DeltaNEC Interbody SystemNexus Spine20260—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+10K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+10K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+10K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+10K243474MagnetOs MISKuros Biosciences B.V20250—
+10K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+10K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+10K243188Cylox® STSignus Medizintechnik GmbH20250—
+10K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+10K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+10K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+10K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+10K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+10K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+10K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+10K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+10K240453ReBOSSISOrthorebirth Co., Ltd.202402
+10K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+10K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+10K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+10K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+10K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—