510(k) Report

Devices descending from K112359

601 later devices reach Prow Fusion through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+5K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+5K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+5K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+5K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+5K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+5K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+5K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+5K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+5K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+5K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+5K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+5K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+5K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+5K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+5K193521Steerable Plateau TiLife Spine, Inc.20201—
+5K193258ProLift Expandable SystemLife Spine, Inc.20203—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K183064TxTi IBF SystemInnovasis, Inc.2019481
+5K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+5K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+5K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+5K183092Kuros TLIF CageKuros Biosciences B.V20190—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+5K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+5K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+5K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+5K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+5K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+5K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+5K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+5K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+5K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+5K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+5K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+5K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+5K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+5K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+5K170235Lucent®Spinal Elements, Inc.2017107—
+5K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+5K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+5K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+5K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+5K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+5K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+5K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+5K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+5K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+5K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+6K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K243474MagnetOs MISKuros Biosciences B.V20250—
+6K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+6K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+6K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+6K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+6K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—