510(k) Report

Devices descending from K983583

965 later devices reach Depuy Acromed Moss and Moss Miami Spinal Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+5K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+5K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+5K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+5K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+5K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+5K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+5K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+5K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+5K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+5K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+5K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+5K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+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—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+5K172941CASCADIA Interbody SystemK2m201852—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+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
+5K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170647Connector SystemOrthofix, Inc.201718—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+5K162921Navigated Instrument SystemOrthofix, Inc.20175—
+5K162764Jazz Frame SystemImplanet, S.A.20176—
+5K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+5K153326Erisma-LP Spinal Fixation SystemClariance, Sas201651
+5K151813Sniper Spine SystemSpine Wave, Inc.20159—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+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—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+5K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+5K121728Tiger Spine SystemCorelink, LLC201250—
+5K121172Reform Pedicle Screw SystemSpinal USA201233—
+5K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+5K100122Modification to Capsure PS SystemSpine Wave, Inc.20102—
+5K083743Capsure PS SystemSpine Wave, Inc.20093—
+5K080767Conquest Spinal SystemLife Spine200821—
+6K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+6K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253249TriALTIS™ Spine SystemMedos International SARL20251—
+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—