510(k) Report

Devices descending from K002858

749 later devices reach Xia Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+9K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+9K172469TiLock Modular Spinal SystemGenesys Spine20170—
+9K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+9K171321K2M Navigation InstrumentsK2m201711
+9K172194Connector SystemOrthofix, Inc.2017162
+9K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+9K162921Navigated Instrument SystemOrthofix, Inc.20175—
+9K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+9K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+9K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+9K161369EVEREST Spinal SystemK2m, Incorporated20169—
+9K151977icotec Pedicle SystemIcotec AG201630—
+9K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+9K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+9K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+9K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+9K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+9K133402K2M Modular HooksK2m, Inc.20140—
+9K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+9K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+9K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+10K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+10K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+10K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+10K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+10K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+10K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+10K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+10K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+10K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+10K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+10K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+10K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+10K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+10K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+10K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+10K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+10K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+10K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+10K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+10K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+10K241846E3D™-C Interbody SystemEvolution Spine20246—
+10K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+10K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+10K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+10K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+10K231658VEOS Spinal Fixation SystemSpineway20230—
+10K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+10K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+10K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+10K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+10K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+10K223494CD Horizon Spinal SystemMedtronic202317—
+10K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+10K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+10K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+10K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+10K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+10K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+10K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+10K203023Pisces Spinal SystemOrtho Development Corporation20210—
+10K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+10K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+10K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+10K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+10K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+10K201006K2M Navigation InstrumentsK2m, Inc.20200—
+10K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+10K190751Connector SystemOrthofix, Inc.20193—
+10K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+10K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+10K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+10K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+10K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+10K181188EVEREST Spinal SystemK2m, Inc.20186—
+10K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+10K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+10K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+10K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+10K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+10K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+11K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+11K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+11K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+11K262094E3D™-C Interbody SystemEvolution Spine20260—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+11K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+11K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+11K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+11K260038E3D™-C Interbody SystemEvolution Spine20261—
+11K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+11K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+11K253331PressON Spinal Fixation SystemNexus Spine20250—
+11K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+11K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—