510(k) Report

Devices descending from K955348

1,019 later devices reach Titanium Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+6K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+6K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K221244CD Horizon™ Spinal SystemMedtronic202220—
+6K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+6K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+6K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+6K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—
+6K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+6K202771CD Horizon Spinal SystemMedtronic202021—
+6K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+6K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+6K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+6K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+6K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+6K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+6K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+6K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+6K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+6K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+6K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+6K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+6K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+6K170647Connector SystemOrthofix, Inc.201718—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+6K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+6K162921Navigated Instrument SystemOrthofix, Inc.20175—
+6K160640PASS XS Spinal SystemMedicrea International SA20160—
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+6K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+6K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+6K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+6K151974Polaris Spinal SystemBiomet Spine201516—
+6K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+6K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+6K151216Everest Spinal SystemK2m, Inc.201511—
+6K151813Sniper Spine SystemSpine Wave, Inc.20159—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+6K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+6K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+6K131833Centurion Poct SystemOrthofix, Inc.20142—
+6K132303Implanet Spine SystemImplanet, S.A.201315—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—