510(k) Report

Devices descending from K013823

921 later devices reach Xia Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K211932Fixxsure Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20211—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+6K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+6K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+6K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+6K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+6K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+6K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+6K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+6K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K192678Genesys Spine Binary® Lumbar Plate SystemGenesys Spine20191—
+6K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+6K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+6K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+6K191217Jazz PFImplanet, S.A.20190—
+6K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+6K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+6K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+6K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+6K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+6K182182YUKON OCT Spinal SystemK2m20185—
+6K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+6K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+6K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+6K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+6K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc.20189—
+6K172941CASCADIA Interbody SystemK2m201852—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+6K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+6K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+6K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+6K161028K2M Growing Spine SystemK2m, Inc.20163—
+6K161369EVEREST Spinal SystemK2m, Incorporated20169—
+6K160362Z-Span Plate SystemZavation, LLC20163—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+6K143350Nile Alternative FixationK2m, Inc.201510—
+6K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+6K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+6K141147Range Spinal SystemK2m, Inc.20141—
+6K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+6K133103Aversion Pedicle Screw SystemK7, LLC20140—
+6K133369Tiger Spine SystemCorelink, LLC201429—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+6K131250Tiger Spine SystemCorelink, LLC201340—
+6K131784Range Spinal SystemK2m, Inc.201334—
+6K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+6K131030Range Spinal SystemK2m, Inc.201334—
+6K130330Range Spinal SystemK2m, Inc.201336—
+6K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+6K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+6K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+6K121020Viper SystemDepuy Spine, Inc.201294—
+6K113058Tiger Spine SystemCorelink, LLC201281—
+6K113044Synthes MirsSynthes Spine2011933
+6K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+6K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+6K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+6K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)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—
+7K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+7K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+7K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—