510(k) Report

Devices descending from K962628

905 later devices reach Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+5K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K200846Balteum™ Lumbar Plate SystemHuvexel Co., Ltd.20204—
+5K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+5K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+5K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+5K190016Lateral Plate SystemCorelink, LLC201915—
+5K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K190584CAYMAN LP Plate SystemK2m, Inc.20192—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+5K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+5K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+5K183214Raven Lumbar Plate SystemChoicespine, LP20192—
+5K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+5K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+5K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+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—
+5K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+5K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+5K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+5K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+5K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+5K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+5K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K172469TiLock Modular Spinal SystemGenesys Spine20170—
+5K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+5K171321K2M Navigation InstrumentsK2m201711
+5K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+5K162921Navigated Instrument SystemOrthofix, Inc.20175—
+5K162764Jazz Frame SystemImplanet, S.A.20176—
+5K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+5K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+5K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+5K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+5K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+5K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+5K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+5K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K150449LITe Plate SystemStryker Corp.201524—
+5K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K140260Skyhawk Lateral Plate SystemOrthofix, Inc.201414—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K131533Cayman MI Plate SystemK2m, Inc.201372—
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+5K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+5K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20134—
+5K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+5K120646Capsure (R) PS SystemSpine Wave, Inc.20120—