510(k) Report

Devices descending from K031672

862 later devices reach Spinal Concepts, Inc. Infix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+7K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+7K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+7K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+7K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+7K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+7K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K183243Velofix TLIF CageU&I Corporation20190—
+7K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+7K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+7K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+7K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+7K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+7K162496Foundation 3D InterbodyCorelink, LLC201782—
+7K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+7K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+7K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+7K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+7K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+7K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+7K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+7K143479Bluefin Interbody SystemTides Medical20152—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+8K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+8K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+8K212358Romero Cervical CageSpineup, Inc.20226—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+8K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+8K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+8K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+8K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+8K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+8K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+8K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+8K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+8K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+8K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+8K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+8K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+8K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+8K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+8K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+8K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+8K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+8K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+8K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+8K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+8K170235Lucent®Spinal Elements, Inc.2017107—
+8K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+8K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+8K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—