510(k) Report

Devices descending from K953915

765 later devices reach Moss Miami Spinal System (Anterior Use) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+5K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+5K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K143631Benefix Interspinous Fixation SystemU&I Corporation20150—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20152—
+5K151813Sniper Spine SystemSpine Wave, Inc.20159—
+5K143110GALAXY MIS Screw SystemBm Korea20152—
+5K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+5K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K143388Affix IIS Spinous Process Plate SystemNu Vasive, Incorporated20150—
+5K143350Nile Alternative FixationK2m, Inc.201510—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K142053Universal Clamp Spinal Fixation SystemZimmer Spine, Inc.201423—
+5K141508Romeo 2 Pad Posterior Axial DeviceSpineart20141—
+5K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K133482Silc Fixation SystemGlobus Medical, Inc.201411—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+5K132395LigapassMedicrea International201323—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K132287Jazz SystemHogan Lovells US LLP201315—
+5K124014Surefix Interspinous Fusion SystemJg Spine, LLC20130—
+5K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+5K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc.201218—
+5K121541Jazz SystemImplanet, S.A.201227—
+5K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+5K113044Synthes MirsSynthes Spine2011933
+5K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+5K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+5K100122Modification to Capsure PS SystemSpine Wave, Inc.20102—
+5K083743Capsure PS SystemSpine Wave, Inc.20093—
+5K080767Conquest Spinal SystemLife Spine200821—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K253249TriALTIS™ Spine SystemMedos International SARL20251—
+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—
+6K243693NEO Pedicle Screw System™Neo Medical SA20240—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240392JAZZ Spinal SystemImplanet20241—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K232628VADER® Pedicle SystemIcotec AG20241—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+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—
+6K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—