510(k) Report

Devices descending from K033901

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+5K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+5K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+5K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+5K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+5K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+5K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+5K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K171321K2M Navigation InstrumentsK2m201711
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+5K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+5K162764Jazz Frame SystemImplanet, S.A.20176—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+5K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+5K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+5K160003Sniper (R) Spine SystemSpine Wave, Inc.20167—
+5K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+5K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K142381Xia 3 Spinal SystemStryker Corp.201483—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+5K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+5K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+6K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+6K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242042TriALTIS™ Spine SystemMedos International SARL20241—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K211993Z-LINKPC SystemZavation Medical Products, LLC20210—