510(k) Report

Devices descending from K033901

737 later devices reach Merlin Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+2K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+2K120091R&D Innovation Pedicle Screw SystemR&D Innovation, LLC20121—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+2K121020Viper SystemDepuy Spine, Inc.201294—
+2K120074Foundation Spinal SystemThe Skeletal Design Partnership, Ltd.20122—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K113173Nanovis Spinal SystemNanovis, LLC20122—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K113044Synthes MirsSynthes Spine2011933
+2K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+2K110551Expedium Spine SystemJohnson & Johnson20111—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+2K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+2K111571Viper SystemsJohnson & Johnson2011203—
+2K101762Viper F2 Facet Fixation SystemDepuy Spine, Inc.20101—
+2K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+2K102020Vega Span Spinous Process Plate SystemSpinefrontier, Inc.20108—
+2K101070Expedium Spine SystemMedos International SARL20102601
+2K100757Tilock Pedicle Screw SystemGenesys Spine201091
+2K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+2K100605Mis SystemSpine Wave, Inc.201033—
+2K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+2K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+2K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K082195Modifications to Expedium Spine SystemDepuy Spine, Inc.2008269—
+2K081252Expedium 4.5MM Spine SystemDepuy Spine, Inc.200844—
+2K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+2K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006424—
+2K061520Viper Spine SystemDepuy Spine, Inc.2006517—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K253249TriALTIS™ Spine SystemMedos International SARL20251—
+3K252437JAZZ Spinal SystemImplanet20250—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+3K240392JAZZ Spinal SystemImplanet20241—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+3K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+3K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K213266Inspan ScrewLES Fusion SystemLespine Innovations, LLC20213—
+3K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K203452Nano FortiFix® SystemNanovis, LLC20200—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+3K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+3K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+3K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+3K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+3K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+3K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+3K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+3K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811