510(k) Report

Devices descending from K841189

2,425 later devices reach Oec/Rezaian Spinal Fixator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+6K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+6K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+6K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+6K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+6K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+6K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+6K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+6K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+6K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+6K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+6K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+6K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+6K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+6K180324Patriot Spinal Fixation SystemValorus Spine20180—
+6K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+6K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+6K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+6K172941CASCADIA Interbody SystemK2m201852—
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K172816TiGer Shark™ SystemChoicespine, LP201859—
+6K171312FortiCore®Nanovis, LLC20183—
+6K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC20189—
+6K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+6K173508Everest Spinal SystemK2m20189—
+6K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+6K173702Juliet Ti LLSpineart20182—
+6K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+6K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+6K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+6K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+6K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+6K173126Arisstos™ Spinal SystemIngenium Spine20171—
+6K172419Velofix™ TLIF CageU&I Corporation20172—
+6K172469TiLock Modular Spinal SystemGenesys Spine20170—
+6K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+6K172083Idys™ ALIF SystemClariance, Sas20177—
+6K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+6K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+6K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+6K172065Scarlet AC-TSpineart20172—
+6K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+6K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+6K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+6K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+6K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+6K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+6K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+6K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+6K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+6K163589SIGN IM NailSign Fracture Care International20170—
+6K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+6K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+6K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+6K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+6K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+6K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+6K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+6K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+6K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+6K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+6K162496Foundation 3D InterbodyCorelink, LLC201782—
+6K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+6K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+6K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+6K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+6K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+6K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+6K163364MOJAVE Expandable Interbody SystemK2m201725—
+6K162921Navigated Instrument SystemOrthofix, Inc.20175—
+6K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+6K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+6K162786PASS LP Spinal SystemMedicrea International SA20176—
+6K162531Sterispine CCSafe Orthopaedics20160—
+6K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+6K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+6K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+6K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+6K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+6K162264Cascadia Interbody SystemK2m, Inc.2016169—
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+6K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+6K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+6K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—