510(k) Report

Devices descending from K950697

849 later devices reach Depuy Motech Moss Miami Spinal System - Pedicle Fixation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+6K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+6K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+6K110551Expedium Spine SystemJohnson & Johnson20111—
+6K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+6K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+6K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+6K101070Expedium Spine SystemMedos International SARL20102601
+6K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+6K100122Modification to Capsure PS SystemSpine Wave, Inc.20102—
+6K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+6K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+6K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+6K083743Capsure PS SystemSpine Wave, Inc.20093—
+6K080767Conquest Spinal SystemLife Spine200821—
+6K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+7K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+7K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K222789VADER® Pedicle System, G21 CementIcotec AG202352
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+7K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+7K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+7K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+7K162367Erisma® LP MISClariance, Sas20162—
+7K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+7K152174Sniper Spine SystemSpine Wave, Inc.20158—
+7K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+7K143350Nile Alternative FixationK2m, Inc.201510—
+7K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+7K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+7K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+7K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+7K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+7K133103Aversion Pedicle Screw SystemK7, LLC20140—
+7K131343Reform Pedicle Screw SystemSpinal USA201331—
+7K130279Reform Pedicle Screw SystemSpinal USA201331—
+7K131030Range Spinal SystemK2m, Inc.201334—
+7K123373Nautilus Spinal SystemLife Spine201317—
+7K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+7K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+7K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+7K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+7K121020Viper SystemDepuy Spine, Inc.201294—
+7K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+7K113044Synthes MirsSynthes Spine2011933
+7K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+7K110906Apex Spine SystemSpinecraft, LLC2011103—
+7K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+7K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+7K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+7K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+7K090320Conquest Spinal SystemLife Spine20092—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—